{
"NDC": [
{
"NDCCode": "75834-131-18",
"PackageDescription": "180 TABLET in 1 BOTTLE (75834-131-18) ",
"NDC11Code": "75834-0131-18",
"ProductNDC": "75834-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemfibrozil",
"NonProprietaryName": "Gemfibrozil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203266",
"LabelerName": "Nivagen Pharmaceuticals, Inc.",
"SubstanceName": "GEMFIBROZIL",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170215",
"SamplePackage": "N",
"IndicationAndUsage": "Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for: 1 Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia., 2 Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL-and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY.",
"Description": "Gemfibrozil tablets, USP 600 mg is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains calcium stearate, NF; microcrystalline cellulose, NF; hydroxypropyl cellulose, NF; polysorbate 80, NF; colloidal silicon dioxide, NF; pregelatinized starch (maize starch), NF; croscarmellose sodium, NF; Opadry white; Opacode Blue. Opadry white contains hypromellose, titanium dioxide, polyethylene glycol 400 and Opacode blue contains shellac, FD&C Blue #1, N-butyl alcohol, titanium dioxide, propylene glycol, isopropyl alcohol. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula. The empirical formula is C15H22O3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58°–61° C. Gemfibrozil is a white solid which is stable under ordinary conditions."
},
{
"NDCCode": "75834-152-18",
"PackageDescription": "180 TABLET, COATED in 1 BOTTLE (75834-152-18) ",
"NDC11Code": "75834-0152-18",
"ProductNDC": "75834-152",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Colesevelam Hydrochloride",
"NonProprietaryName": "Colesevelam Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20201204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212050",
"LabelerName": "Nivagen Pharmaceuticals, Inc.",
"SubstanceName": "COLESEVELAM HYDROCHLORIDE",
"StrengthNumber": "625",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201204",
"SamplePackage": "N",
"IndicationAndUsage": "Colesevelam hydrochloride is a bile acid sequestrant indicated as an adjunct to diet and exercise to: reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia ( 1.1). reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH), unable to reach LDL-C target levels despite an adequate trial of diet and lifestyle modification ( 1.1). : 1 improve glycemic control in adults with type 2 diabetes mellitus ( 1.2). .",
"Description": "Colesevelam hydrochloride is a non-absorbed, polymeric, lipid-lowering and glucose-lowering agent for oral administration. Colesevelam hydrochloride is a high-capacity bile acid-binding molecule. Colesevelam hydrochloride is poly(allylamine hydrochloride) cross-linked with epichlorohydrin and alkylated with 1-bromodecane and (6-bromohexyl)-trimethylammonium bromide. The chemical name (IUPAC) of colesevelam hydrochloride is allylamine polymer with 1-chloro-2,3-epoxypropane, [6-(allylamino)-hexyl]trimethylammonium chloride and N-allyldecylamine, hydrochloride. The chemical structure of colesevelam hydrochloride is represented by the following formula. wherein (a) represents allyl amine monomer units that have not been alkylated by either of the 1-bromodecane or (6-bromohexyl)-trimethylammonium bromide alkylating agents or cross-linked by epichlorohydrin; (b) represents allyl amine units that have undergone cross-linking with epichlorohydrin; (c) represents allyl amine units that have been alkylated with a decyl group; (d) represents allyl amine units that have been alkylated with a (6-trimethylammonium) hexyl group, and m represents a number ≥ 100 to indicate an extended polymer network. A small amount of the amines are dialkylated and are not depicted in the formula above. No regular order of the groups is implied by the structure; cross-linking and alkylation are expected to occur randomly along the polymer chains. A large amount of the amines are protonated. The polymer is depicted in the hydrochloride form; a small amount of the halides are bromide. Colesevelam hydrochloride is hydrophilic and insoluble in water. Colesevelam hydrochloride tablets are off-white to light yellow, capsule shaped, coated, tablets each containing 625 mg colesevelam hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose 2910, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000. The tablets are imprinted using a black ink of opacode black S-1-17823 containing ferrosoferric oxide, propylene glycol and shellac."
},
{
"NDCCode": "75834-131-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (75834-131-05) ",
"NDC11Code": "75834-0131-05",
"ProductNDC": "75834-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemfibrozil",
"NonProprietaryName": "Gemfibrozil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203266",
"LabelerName": "Nivagen Pharmaceuticals, Inc.",
"SubstanceName": "GEMFIBROZIL",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170215",
"SamplePackage": "N",
"IndicationAndUsage": "Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for: 1 Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia., 2 Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL-and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY.",
"Description": "Gemfibrozil tablets, USP 600 mg is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains calcium stearate, NF; microcrystalline cellulose, NF; hydroxypropyl cellulose, NF; polysorbate 80, NF; colloidal silicon dioxide, NF; pregelatinized starch (maize starch), NF; croscarmellose sodium, NF; Opadry white; Opacode Blue. Opadry white contains hypromellose, titanium dioxide, polyethylene glycol 400 and Opacode blue contains shellac, FD&C Blue #1, N-butyl alcohol, titanium dioxide, propylene glycol, isopropyl alcohol. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula. The empirical formula is C15H22O3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58°–61° C. Gemfibrozil is a white solid which is stable under ordinary conditions."
},
{
"NDCCode": "75834-131-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (75834-131-60) ",
"NDC11Code": "75834-0131-60",
"ProductNDC": "75834-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemfibrozil",
"NonProprietaryName": "Gemfibrozil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203266",
"LabelerName": "Nivagen Pharmaceuticals, Inc.",
"SubstanceName": "GEMFIBROZIL",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170215",
"SamplePackage": "N",
"IndicationAndUsage": "Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for: 1 Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia., 2 Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL-and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY.",
"Description": "Gemfibrozil tablets, USP 600 mg is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains calcium stearate, NF; microcrystalline cellulose, NF; hydroxypropyl cellulose, NF; polysorbate 80, NF; colloidal silicon dioxide, NF; pregelatinized starch (maize starch), NF; croscarmellose sodium, NF; Opadry white; Opacode Blue. Opadry white contains hypromellose, titanium dioxide, polyethylene glycol 400 and Opacode blue contains shellac, FD&C Blue #1, N-butyl alcohol, titanium dioxide, propylene glycol, isopropyl alcohol. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula. The empirical formula is C15H22O3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58°–61° C. Gemfibrozil is a white solid which is stable under ordinary conditions."
},
{
"NDCCode": "45865-131-18",
"PackageDescription": "18 TABLET, FILM COATED in 1 BLISTER PACK (45865-131-18) ",
"NDC11Code": "45865-0131-18",
"ProductNDC": "45865-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin Dihydrate",
"NonProprietaryName": "Azithromycin Dihydrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208250",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210316",
"SamplePackage": "N",
"IndicationAndUsage": "Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].",
"Description": "Azithromycin Tablets, USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranos yl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38H 72N 2O 12, and its molecular weight is 749.00. Azithromycin has the following structural formula:. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 12∙2H 2O and a molecular weight of 785.0. Azithromycin is supplied as tablets containing azithromycin dihydrate equivalent to 250 mg azithromycin and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Blue #1 aluminum lake and lecithin, FD&C Red #40 aluminum Lake, FD&C Yellow #6 aluminum Lake, macrogol/PEG, magnesium stearate, polyvinyl alcohol, pregelatinized starch, talc, and titanium dioxide."
},
{
"NDCCode": "49035-131-89",
"PackageDescription": "18 BLISTER PACK in 1 CARTON (49035-131-89) > 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "49035-0131-89",
"ProductNDC": "49035-131",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equate Suphedrine Pe",
"NonProprietaryName": "Phenylephrine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140321",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Wal-Mart Stores Inc",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-03-14",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "53943-131-02",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (53943-131-02) / 18 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "53943-0131-02",
"ProductNDC": "53943-131",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Suphedrine Pe",
"NonProprietaryName": "Phenylephrine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20111206",
"EndMarketingDate": "20250831",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "DISCOUNT DRUG MART",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20111206",
"EndMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and nasal congestion associated with sinusitis. temporarily relieves sinus congestion and pressure."
},
{
"NDCCode": "53943-131-03",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (53943-131-03) / 18 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "53943-0131-03",
"ProductNDC": "53943-131",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Suphedrine Pe",
"NonProprietaryName": "Phenylephrine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20111206",
"EndMarketingDate": "20250831",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "DISCOUNT DRUG MART",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20111206",
"EndMarketingDatePackage": "20250831",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and nasal congestion associated with sinusitis. temporarily relieves sinus congestion and pressure."
},
{
"NDCCode": "54555-131-02",
"PackageDescription": "18.9 L in 1 JUG (54555-131-02) ",
"NDC11Code": "54555-0131-02",
"ProductNDC": "54555-131",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alco-gel",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200701",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Brainerd Chemical Company Inc.,",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "750",
"StrengthUnit": "mL/L",
"Status": "Deprecated",
"LastUpdate": "2020-10-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N"
},
{
"NDCCode": "57344-131-02",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (57344-131-02) > 18 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "57344-0131-02",
"ProductNDC": "57344-131",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Phenylephrine Hydrochloride",
"NonProprietaryName": "Phenylephrine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121222",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "AAA Pharmaceutical, Inc.",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20121222",
"SamplePackage": "N"
},
{
"NDCCode": "57344-131-03",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (57344-131-03) / 18 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "57344-0131-03",
"ProductNDC": "57344-131",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Phenylephrine Hydrochloride",
"NonProprietaryName": "Phenylephrine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120413",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "AAA Pharmaceutical, Inc.",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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},
{
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Phenylephrine Hydrochloride",
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"MarketingCategoryName": "OTC MONOGRAPH FINAL",
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"LabelerName": "AAA Pharmaceutical, Inc.",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
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{
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"ProductTypeName": "HUMAN OTC DRUG",
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"NonProprietaryName": "Alcohol",
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"ApplicationNumber": "part333E",
"LabelerName": "Inopak. Ltd",
"SubstanceName": "ALCOHOL",
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"StrengthUnit": "mL/100mL",
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"ProductTypeName": "HUMAN OTC DRUG",
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"RouteName": "ORAL",
"StartMarketingDate": "20231030",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
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"LabelerName": "AMERIFOODS TRADING COMPANY",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
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"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
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"IndicationAndUsage": "temporarily relieves sinus congestion and pressure. temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies."
},
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen And Ibuprofen",
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"DosageFormName": "TABLET",
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"StartMarketingDate": "20230724",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216592",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "ACETAMINOPHEN; IBUPROFEN",
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"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
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{
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"PackageDescription": "18 TABLET in 1 BOTTLE (70038-131-81) ",
"NDC11Code": "70038-0131-81",
"ProductNDC": "70038-131",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216592",
"LabelerName": "RAONBIO CORP",
"SubstanceName": "ACETAMINOPHEN; IBUPROFEN",
"StrengthNumber": "250; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20240101",
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"IndicationAndUsage": "■ temporarily relieves minor aches and pains due to: ■ headache ■ toothache ■ backache ■ menstrual cramps ■ muscular aches ■ minor pain of arthritis."
},
{
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"PackageDescription": "50 VIAL, GLASS in 1 KIT (71919-821-18) / 1 KIT in 1 VIAL, GLASS (71919-821-01) * 750 PELLET in 1 VIAL, GLASS (68428-127-01) * 750 PELLET in 1 VIAL, GLASS (68428-124-01) * 750 PELLET in 1 VIAL, GLASS (68428-123-01) * 750 PELLET in 1 VIAL, GLASS (68428-122-01) * 750 PELLET in 1 VIAL, GLASS (68428-119-01) * 750 PELLET in 1 VIAL, GLASS (68428-146-01) * 750 PELLET in 1 VIAL, GLASS (68428-099-01) * 750 PELLET in 1 VIAL, GLASS (68428-098-01) * 750 PELLET in 1 VIAL, GLASS (68428-097-01) * 750 PELLET in 1 VIAL, GLASS (68428-144-01) * 750 PELLET in 1 VIAL, GLASS (68428-142-01) * 750 PELLET in 1 VIAL, GLASS (68428-148-01) * 750 PELLET in 1 VIAL, GLASS (68428-147-01) * 750 PELLET in 1 VIAL, GLASS (68428-105-01) * 750 PELLET in 1 VIAL, GLASS (68428-104-01) * 750 PELLET in 1 VIAL, GLASS (68428-103-01) * 750 PELLET in 1 VIAL, GLASS (68428-102-01) * 350 PELLET in 1 VIAL, GLASS (71919-768-01) * 750 PELLET in 1 VIAL, GLASS (68428-101-01) * 750 PELLET in 1 VIAL, GLASS (68428-154-01) * 750 PELLET in 1 VIAL, GLASS (68428-112-01) * 750 PELLET in 1 VIAL, GLASS (68428-111-01) * 750 PELLET in 1 VIAL, GLASS (68428-109-01) * 750 PELLET in 1 VIAL, GLASS (68428-108-01) * 750 PELLET in 1 VIAL, GLASS (68428-107-01) * 750 PELLET in 1 VIAL, GLASS (68428-106-01) * 750 PELLET in 1 VIAL, GLASS (68428-149-01) * 750 PELLET in 1 VIAL, GLASS (68428-118-01) * 750 PELLET in 1 VIAL, GLASS (68428-117-01) * 750 PELLET in 1 VIAL, GLASS (68428-115-01) * 750 PELLET in 1 VIAL, GLASS (68428-156-01) * 750 PELLET in 1 VIAL, GLASS (68428-114-01) * 750 PELLET in 1 VIAL, GLASS (68428-155-01) * 750 PELLET in 1 VIAL, GLASS (68428-086-01) * 750 PELLET in 1 VIAL, GLASS (68428-095-01) * 750 PELLET in 1 VIAL, GLASS (68428-138-01) * 750 PELLET in 1 VIAL, GLASS (68428-092-01) * 750 PELLET in 1 VIAL, GLASS (68428-091-01) * 750 PELLET in 1 VIAL, GLASS (68428-085-01) * 750 PELLET in 1 VIAL, GLASS (68428-090-01) * 750 PELLET in 1 VIAL, GLASS (68428-134-01) * 750 PELLET in 1 VIAL, GLASS (68428-133-01) * 750 PELLET in 1 VIAL, GLASS (68428-084-01) * 750 PELLET in 1 VIAL, GLASS (68428-083-01) * 750 PELLET in 1 VIAL, GLASS (68428-082-01) * 750 PELLET in 1 VIAL, GLASS (68428-080-01) * 750 PELLET in 1 VIAL, GLASS (68428-131-01) * 750 PELLET in 1 VIAL, GLASS (68428-078-01) * 750 PELLET in 1 VIAL, GLASS (68428-125-01) * 750 PELLET in 1 VIAL, GLASS (68428-077-01) ",
"NDC11Code": "71919-0821-18",
"ProductNDC": "71919-821",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "30c Homeopathic Remedy Kit",
"NonProprietaryName": "50 Remedy Kit",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20240221",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20240221",
"SamplePackage": "N",
"IndicationAndUsage": "Acon nap fear. Aesculus hipp hemorrhoids. Allium cepa head cold. Antimon crud warts. Apis mel stings. Arnica bruises. Arsenicum alb vomiting. Belladonna fever. Bellis bruised soreness. Berber vulg itching. Bryonia worse motion. Calc carb overwork. Caulophyllum cramps. Causticum hoarseness. Chamomilla irritability. Cimicifuga minor back pain. Coffea cruda sleeplessness. Drosera cough. Eupatorium perf flu-like symptoms. Euphrasia eye irritation. Ferrum phos low fever. Gelsemium lethargy. Hamamelis varicose veins. Hepar sulph calc croupiness. Hydrastis sinuses. Hypericum shooting pain. Ignatia sadness. Ipecac nausea. Kali bic sinuses. Kali carb sour belching. Kali mur congested ears. Kali phos irritability. Lachesis sore throat. Ledum black eyes. Lycopodium digestion. Mag phos cramps. Nat mur sneezing. Nux vom vomiting. Petroleum nausea. Phosphoricum ac headache. Phytolacca sore throat. Podoph pelt diarrhea. Pulsatilla weeping. Rhus tox better motion. Ruta bruised feeling. Sepia indifference. Staphysag anger. Sulphur skin problems. Symphytum prickling pain. Thuja occ warts."
},
{
"NDCCode": "72036-131-02",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (72036-131-02) / 18 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "72036-0131-02",
"ProductNDC": "72036-131",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Congestion Pe",
"NonProprietaryName": "Phenylephrine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130611",
"EndMarketingDate": "20250831",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Harris Teeter",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130611",
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"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and nasal congestion associated with sinusitis. temporarily relieves sinus congestion and pressure."
},
{
"NDCCode": "72036-131-03",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (72036-131-03) / 18 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "72036-0131-03",
"ProductNDC": "72036-131",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Congestion Pe",
"NonProprietaryName": "Phenylephrine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130611",
"EndMarketingDate": "20250831",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Harris Teeter",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130611",
"EndMarketingDatePackage": "20250831",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and nasal congestion associated with sinusitis. temporarily relieves sinus congestion and pressure."
},
{
"NDCCode": "72476-131-81",
"PackageDescription": "18 TABLET in 1 BOTTLE (72476-131-81) ",
"NDC11Code": "72476-0131-81",
"ProductNDC": "72476-131",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen And Ibuprofen (nsaid)",
"NonProprietaryName": "Acetaminophen And Ibuprofen (nsaid)",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230720",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216592",
"LabelerName": "RETAIL BUSINESS SERVICES,LLC",
"SubstanceName": "IBUPROFEN; ACETAMINOPHEN",
"StrengthNumber": "125; 250",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230720",
"SamplePackage": "N",
"IndicationAndUsage": "■ temporarily relieves minor aches and pains due to: ■ headache ■ toothache ■ backache ■ menstrual cramps ■ muscular aches ■ minor pain of arthritis."
},
{
"NDCCode": "75834-148-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (75834-148-30) ",
"NDC11Code": "75834-0148-30",
"ProductNDC": "75834-148",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209695",
"LabelerName": "NIVAGEN PHARMACEUTICALS, INC.",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171211",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine tablets are indicated for the treatment of: 1 Major Depressive Disorder (MDD). The efficacy of fluoxetine in MDD was established in one 5-week trial, three 6-week trials, and one maintenance study in adults. The efficacy of fluoxetine was also established in two 8- to 9-week trials in pediatric patients 8 to 18 years of age [see Clinical Studies ( 14.1)]. , 2 Obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). The efficacy of fluoxetine in OCD was demonstrated in two 13-week trials in adults and one 13-week trial in pediatric patients 7 to 17 years of age [see Clinical Studies ( 14.2) ]. , 3 Binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa. The efficacy of fluoxetine in Bulimia Nervosa was demonstrated in two 8-week trials and one 16-week trial in adults [see Clinical Studies ( 14.3)]. , 4 Panic Disorder, with or without agoraphobia. The efficacy of fluoxetine in Panic Disorder was demonstrated in two 12-week trials in adults [see Clinical Studies ( 14.4)]. .",
"Description": "Fluoxetine hydrochloride USP is a selective serotonin reuptake inhibitor for oral administration. It is designated(±)- N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each scored tablet contains fluoxetine hydrochloride USP equivalent to 60 mg (194 µmol) of fluoxetine. In addition, each scored tablet also contains the following inactive ingredients: corn starch, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol and titanium dioxide."
},
{
"NDCCode": "75834-294-01",
"PackageDescription": "100 mL in 1 BOTTLE (75834-294-01) ",
"NDC11Code": "75834-0294-01",
"ProductNDC": "75834-294",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erythromycin Ethylsuccinate",
"NonProprietaryName": "Erythromycin Ethylsuccinate",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20230201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216212",
"LabelerName": "Nivagen Pharmaceuticals, Inc.",
"SubstanceName": "ERYTHROMYCIN ETHYLSUCCINATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2024-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230201",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate for oral suspension and other antibacterial drugs, erythromycin ethylsuccinate for oral suspension 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 ethylsuccinate for oral suspension is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below: Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae, or 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 pneumoniae or Streptococcus pyogenes. Listeriosis caused by Listeria monocytogenes. 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. 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).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 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.Syphilis Caused by Treponema pallidum Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy.Erythromycins are indicated for the 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. 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.ProphylaxisPrevention of Initial Attacks of Rheumatic FeverPenicillin 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). Erythromycin is indicated for the treatment of penicillin-allergic patients.1 The therapeutic dose should be administered for 10 days.Prevention of Recurrent Attacks of Rheumatic FeverPenicillin 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 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. The base, the stearate salt are practically insoluble in water, freely soluble in acetone, in anhydrous ethanol and in methanol. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethyl succinate). The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Erythromycin ethylsuccinate for oral suspension, USP 200 mg/5 mL when reconstituted with water, forms a suspension containing erythromycin ethylsuccinate equivalent to 200 mg erythromycin per 5 mL (teaspoonful) or 100 mg per 2.5 mL (dropperful) with an appealing banana flavor. Erythromycin ethylsuccinate for oral suspension, USP 400 mg/5 mL when reconstituted with water, forms a suspension containing erythromycin ethylsuccinate equivalent to 400 mg of erythromycin per 5 mL (teaspoonful) with an appealing banana flavor. These products are intended primarily for pediatric use but can also be used in adults.Inactive IngredientsErythromycin ethylsuccinate for oral suspension, USP 200 mg/5 mL, Erythromycin ethylsuccinate for oral suspension, USP 400 mg/5 mL: Banana flavour, caster sugar N° 1 400, neelinatural plain caramel powder, polysorbate 80, sodium citrate and xanthan gum."
},
{
"NDCCode": "75834-295-01",
"PackageDescription": "100 mL in 1 BOTTLE (75834-295-01) ",
"NDC11Code": "75834-0295-01",
"ProductNDC": "75834-295",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erythromycin Ethylsuccinate",
"NonProprietaryName": "Erythromycin Ethylsuccinate",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20230201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216212",
"LabelerName": "Nivagen Pharmaceuticals, Inc.",
"SubstanceName": "ERYTHROMYCIN ETHYLSUCCINATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2024-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230201",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate for oral suspension and other antibacterial drugs, erythromycin ethylsuccinate for oral suspension 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 ethylsuccinate for oral suspension is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below: Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae, or 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 pneumoniae or Streptococcus pyogenes. Listeriosis caused by Listeria monocytogenes. 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. 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).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 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.Syphilis Caused by Treponema pallidum Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy.Erythromycins are indicated for the 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. 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.ProphylaxisPrevention of Initial Attacks of Rheumatic FeverPenicillin 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). Erythromycin is indicated for the treatment of penicillin-allergic patients.1 The therapeutic dose should be administered for 10 days.Prevention of Recurrent Attacks of Rheumatic FeverPenicillin 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 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. The base, the stearate salt are practically insoluble in water, freely soluble in acetone, in anhydrous ethanol and in methanol. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethyl succinate). The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Erythromycin ethylsuccinate for oral suspension, USP 200 mg/5 mL when reconstituted with water, forms a suspension containing erythromycin ethylsuccinate equivalent to 200 mg erythromycin per 5 mL (teaspoonful) or 100 mg per 2.5 mL (dropperful) with an appealing banana flavor. Erythromycin ethylsuccinate for oral suspension, USP 400 mg/5 mL when reconstituted with water, forms a suspension containing erythromycin ethylsuccinate equivalent to 400 mg of erythromycin per 5 mL (teaspoonful) with an appealing banana flavor. These products are intended primarily for pediatric use but can also be used in adults.Inactive IngredientsErythromycin ethylsuccinate for oral suspension, USP 200 mg/5 mL, Erythromycin ethylsuccinate for oral suspension, USP 400 mg/5 mL: Banana flavour, caster sugar N° 1 400, neelinatural plain caramel powder, polysorbate 80, sodium citrate and xanthan gum."
},
{
"NDCCode": "75834-338-01",
"PackageDescription": "1 POWDER, FOR SOLUTION in 1 PACKET (75834-338-01) ",
"NDC11Code": "75834-0338-01",
"ProductNDC": "75834-338",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Potassium",
"NonProprietaryName": "Diclofenac Potassium",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20251215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217010",
"LabelerName": "Nivagen Pharmaceuticals, Inc.",
"SubstanceName": "DICLOFENAC POTASSIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251215",
"SamplePackage": "N",
"IndicationAndUsage": "Diclofenac potassium for oral solution is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older). Limitations of Use: 1 Diclofenac potassium for oral solution is not indicated for the prophylactic therapy of migraine., 2 The safety and effectiveness of diclofenac potassium for oral solution have not been established for cluster headache, which is present in an older, predominantly male population.",
"Description": "Diclofenac potassium for oral solution USP, 50 mg is a nonsteroidal anti-inflammatory drug, available as a buffered soluble powder, designed to be mixed with water prior to oral administration. Diclofenac potassium for oral solution USP, 50 mg is a white to off-white buffered, flavored powder for oral solution packaged in individual unit dose packets. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid monopotassium salt. The molecular weight is 334.25. Its molecular formula is C 14H 10Cl 2NKO 2, and it has the following structure. The inactive ingredients in diclofenac potassium for oral solution USP, 50 mg include: Potassium bicarbonate, glyceryl behenate, mannitol, natural peppermint flavor and sucralose."
},
{
"NDCCode": "75834-338-02",
"PackageDescription": "9 POWDER, FOR SOLUTION in 1 CARTON (75834-338-02) ",
"NDC11Code": "75834-0338-02",
"ProductNDC": "75834-338",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Potassium",
"NonProprietaryName": "Diclofenac Potassium",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20251215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217010",
"LabelerName": "Nivagen Pharmaceuticals, Inc.",
"SubstanceName": "DICLOFENAC POTASSIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251215",
"SamplePackage": "N",
"IndicationAndUsage": "Diclofenac potassium for oral solution is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older). Limitations of Use: 1 Diclofenac potassium for oral solution is not indicated for the prophylactic therapy of migraine., 2 The safety and effectiveness of diclofenac potassium for oral solution have not been established for cluster headache, which is present in an older, predominantly male population.",
"Description": "Diclofenac potassium for oral solution USP, 50 mg is a nonsteroidal anti-inflammatory drug, available as a buffered soluble powder, designed to be mixed with water prior to oral administration. Diclofenac potassium for oral solution USP, 50 mg is a white to off-white buffered, flavored powder for oral solution packaged in individual unit dose packets. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid monopotassium salt. The molecular weight is 334.25. Its molecular formula is C 14H 10Cl 2NKO 2, and it has the following structure. The inactive ingredients in diclofenac potassium for oral solution USP, 50 mg include: Potassium bicarbonate, glyceryl behenate, mannitol, natural peppermint flavor and sucralose."
},
{
"NDCCode": "42571-131-29",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (42571-131-29) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "42571-0131-29",
"ProductNDC": "42571-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nevirapine",
"NonProprietaryName": "Nevirapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120522",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203080",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "NEVIRAPINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120522",
"SamplePackage": "N",
"IndicationAndUsage": "Nevirapine tablet is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older [see Clinical Studies (14.1, 14.2)] . Limitations of Use. Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine tablet is not recommended to be initiated, unless the benefit outweighs the risk, in: 1 adult females with CD4 +cell counts greater than 250 cells/mm 3or , 2 adult males with CD4 +cell counts greater than 400 cells/mm 3[see Warnings and Precautions (5.1)] . .",
"Description": "Nevirapine tablets USP, 200 mg is the brand name for nevirapine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) with activity against Human Immunodeficiency Virus Type 1 (HIV-1). Nevirapine USP is structurally a member of the dipyridodiazepinone chemical class of compounds. The chemical name of nevirapine is 11-cyclopropyl-5, 11-dihydro-4-methyl-6H-dipyrido [3,2-b:2',3'-e][1,4] diazepin-6-one. Nevirapine USP is a white to off-white crystalline powder with the molecular weight of 266.30 and the molecular formula C 15H 14N 4O. Nevirapine has the following structural formula:. Nevirapine tablets USP, 200 mg is for oral administration. Each tablet contains 200 mg of nevirapine anhydrous and the inactive ingredients microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, magnesium stearate, povidone, and Sodium starch glycolate."
},
{
"NDCCode": "42571-131-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (42571-131-60) ",
"NDC11Code": "42571-0131-60",
"ProductNDC": "42571-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nevirapine",
"NonProprietaryName": "Nevirapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120522",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203080",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "NEVIRAPINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120522",
"SamplePackage": "N",
"IndicationAndUsage": "Nevirapine tablet is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older [see Clinical Studies (14.1, 14.2)] . Limitations of Use. Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine tablet is not recommended to be initiated, unless the benefit outweighs the risk, in: 1 adult females with CD4 +cell counts greater than 250 cells/mm 3or , 2 adult males with CD4 +cell counts greater than 400 cells/mm 3[see Warnings and Precautions (5.1)] . .",
"Description": "Nevirapine tablets USP, 200 mg is the brand name for nevirapine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) with activity against Human Immunodeficiency Virus Type 1 (HIV-1). Nevirapine USP is structurally a member of the dipyridodiazepinone chemical class of compounds. The chemical name of nevirapine is 11-cyclopropyl-5, 11-dihydro-4-methyl-6H-dipyrido [3,2-b:2',3'-e][1,4] diazepin-6-one. Nevirapine USP is a white to off-white crystalline powder with the molecular weight of 266.30 and the molecular formula C 15H 14N 4O. Nevirapine has the following structural formula:. Nevirapine tablets USP, 200 mg is for oral administration. Each tablet contains 200 mg of nevirapine anhydrous and the inactive ingredients microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, magnesium stearate, povidone, and Sodium starch glycolate."
},
{
"NDCCode": "51862-571-30",
"PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (51862-571-30) ",
"NDC11Code": "51862-0571-30",
"ProductNDC": "51862-571",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201002",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA050795",
"LabelerName": "Mayne Pharma Commercial LLC",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201002",
"SamplePackage": "N",
"IndicationAndUsage": "Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: 1 Rickettsial infections (1.1), 2 Sexually transmitted infections (1.2), 3 Respiratory tract infections (1.3), 4 Specific bacterial infections (1.4), 5 Ophthalmic infections (1.5), 6 Anthrax, including inhalational anthrax (post-exposure) (1.6), 7 Alternative treatment for selected infections when penicillin is contraindicated (1.7), 8 Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8), 9 Prophylaxis of malaria (1.9).",
"Description": "Doxycycline hyclate delayed-release tablets, contain specially coated pellets of doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration. The structural formula for doxycycline hyclate is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6- methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 50 mg, 75 mg, 80 mg, 100 mg, 150 mg or 200 mg (equivalent to doxycycline hyclate 57.7 mg, 86.6 mg, 92.3 mg, 115.4 mg, 173.1 mg or 230.8 mg). Inactive ingredients in the tablet formulation are: lactose monohydrate; microcrystalline cellulose; sodium lauryl sulfate; sodium chloride; talc; anhydrous lactose; corn starch; crospovidone; magnesium stearate; cellulosic polymer coating. Each doxycycline hyclate delayed-release tablets 50 mg tablet contains 3 mg (0.131 mEq) of sodium, each doxycycline hyclate delayed-release tablets 75 mg tablet contains 4.5 mg (0.196 mEq) of sodium, each doxycycline hyclate delayed-release tablets 80 mg tablet contains 4.8 mg (0.209 mEq) of sodium, each doxycycline hyclate delayed-release tablets 100 mg tablet contains 6 mg (0.261 mEq) of sodium, each doxycycline hyclate delayed-release tablets 150 mg tablet contains 9 mg (0.392 mEq) of sodium, and each doxycycline hyclate delayed-release tablets 200 mg tablet contains 12 mg (0.522 mEq) of sodium."
},
{
"NDCCode": "55292-131-60",
"PackageDescription": "60 PACKAGE in 1 BOX (55292-131-60) / 6 AMPULE in 1 PACKAGE (55292-131-06) / 1 mL in 1 AMPULE (55292-131-01) ",
"NDC11Code": "55292-0131-60",
"ProductNDC": "55292-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Signifor",
"NonProprietaryName": "Pasireotide",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20121214",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200677",
"LabelerName": "Recordati Rare Diseases, Inc.",
"SubstanceName": "PASIREOTIDE",
"StrengthNumber": ".3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121214",
"SamplePackage": "N",
"IndicationAndUsage": "SIGNIFOR is a somatostatin analog indicated for the treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative (1).",
"Description": "SIGNIFOR (pasireotide) injection is prepared as a sterile solution of pasireotide diaspartate in a tartaric acid buffer for administration by subcutaneous injection. SIGNIFOR is a somatostatin analog. Pasireotide diaspartate, chemically known as (2-Aminoethyl) carbamic acid (2R,5S,8S,11S,14R,17S,19aS)-11-(4-aminobutyl)-5-benzyl-8-(4-benzyloxybenzyl)-14-(1H-indol-3-ylmethyl)-4,7,10,13,16,19-hexaoxo-17-phenyloctadecahydro-3a,6,9,12,15,18-hexaazacyclopentacyclooctadecen-2-yl ester, di[(S)-2-aminosuccinic acid] salt, is a cyclohexapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin. The molecular formula of pasireotide diaspartate is C58H66N10O9 2 C4H7NO4 and the molecular weight is 1313.41 g/mol. The structural formula is. SIGNIFOR is supplied as a sterile solution in a single-dose, 1 mL colorless glass ampule containing pasireotide in 0.3 mg/mL, 0.6 mg/mL, or 0.9 mg/mL strengths for subcutaneous injection. Each glass ampule contains."
},
{
"NDCCode": "57627-131-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (57627-131-02) > 30 mL in 1 BOTTLE (57627-131-01) ",
"NDC11Code": "57627-0131-02",
"ProductNDC": "57627-131",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Desert Beige Perfecting Makeup Spf 25",
"ProprietaryNameSuffix": "Merle Norman",
"NonProprietaryName": "Octinoxate, Titanium Dioxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120822",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Merle Norman Cosmetics, Inc",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "2.25; 2.13",
"StrengthUnit": "g/30mL; g/30mL",
"Status": "Deprecated",
"LastUpdate": "2021-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20120822",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>75834-131-18</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (75834-131-18) </PackageDescription>
<NDC11Code>75834-0131-18</NDC11Code>
<ProductNDC>75834-131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gemfibrozil</ProprietaryName>
<NonProprietaryName>Gemfibrozil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203266</ApplicationNumber>
<LabelerName>Nivagen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GEMFIBROZIL</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for: 1 Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia., 2 Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL-and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY.</IndicationAndUsage>
<Description>Gemfibrozil tablets, USP 600 mg is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains calcium stearate, NF; microcrystalline cellulose, NF; hydroxypropyl cellulose, NF; polysorbate 80, NF; colloidal silicon dioxide, NF; pregelatinized starch (maize starch), NF; croscarmellose sodium, NF; Opadry white; Opacode Blue. Opadry white contains hypromellose, titanium dioxide, polyethylene glycol 400 and Opacode blue contains shellac, FD&C Blue #1, N-butyl alcohol, titanium dioxide, propylene glycol, isopropyl alcohol. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula. The empirical formula is C15H22O3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58°–61° C. Gemfibrozil is a white solid which is stable under ordinary conditions.</Description>
</NDC>
<NDC>
<NDCCode>75834-152-18</NDCCode>
<PackageDescription>180 TABLET, COATED in 1 BOTTLE (75834-152-18) </PackageDescription>
<NDC11Code>75834-0152-18</NDC11Code>
<ProductNDC>75834-152</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Colesevelam Hydrochloride</ProprietaryName>
<NonProprietaryName>Colesevelam Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212050</ApplicationNumber>
<LabelerName>Nivagen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>COLESEVELAM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>625</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Colesevelam hydrochloride is a bile acid sequestrant indicated as an adjunct to diet and exercise to: reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia ( 1.1). reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH), unable to reach LDL-C target levels despite an adequate trial of diet and lifestyle modification ( 1.1). : 1 improve glycemic control in adults with type 2 diabetes mellitus ( 1.2). .</IndicationAndUsage>
<Description>Colesevelam hydrochloride is a non-absorbed, polymeric, lipid-lowering and glucose-lowering agent for oral administration. Colesevelam hydrochloride is a high-capacity bile acid-binding molecule. Colesevelam hydrochloride is poly(allylamine hydrochloride) cross-linked with epichlorohydrin and alkylated with 1-bromodecane and (6-bromohexyl)-trimethylammonium bromide. The chemical name (IUPAC) of colesevelam hydrochloride is allylamine polymer with 1-chloro-2,3-epoxypropane, [6-(allylamino)-hexyl]trimethylammonium chloride and N-allyldecylamine, hydrochloride. The chemical structure of colesevelam hydrochloride is represented by the following formula. wherein (a) represents allyl amine monomer units that have not been alkylated by either of the 1-bromodecane or (6-bromohexyl)-trimethylammonium bromide alkylating agents or cross-linked by epichlorohydrin; (b) represents allyl amine units that have undergone cross-linking with epichlorohydrin; (c) represents allyl amine units that have been alkylated with a decyl group; (d) represents allyl amine units that have been alkylated with a (6-trimethylammonium) hexyl group, and m represents a number ≥ 100 to indicate an extended polymer network. A small amount of the amines are dialkylated and are not depicted in the formula above. No regular order of the groups is implied by the structure; cross-linking and alkylation are expected to occur randomly along the polymer chains. A large amount of the amines are protonated. The polymer is depicted in the hydrochloride form; a small amount of the halides are bromide. Colesevelam hydrochloride is hydrophilic and insoluble in water. Colesevelam hydrochloride tablets are off-white to light yellow, capsule shaped, coated, tablets each containing 625 mg colesevelam hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose 2910, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000. The tablets are imprinted using a black ink of opacode black S-1-17823 containing ferrosoferric oxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>75834-131-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (75834-131-05) </PackageDescription>
<NDC11Code>75834-0131-05</NDC11Code>
<ProductNDC>75834-131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gemfibrozil</ProprietaryName>
<NonProprietaryName>Gemfibrozil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203266</ApplicationNumber>
<LabelerName>Nivagen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GEMFIBROZIL</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for: 1 Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia., 2 Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL-and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY.</IndicationAndUsage>
<Description>Gemfibrozil tablets, USP 600 mg is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains calcium stearate, NF; microcrystalline cellulose, NF; hydroxypropyl cellulose, NF; polysorbate 80, NF; colloidal silicon dioxide, NF; pregelatinized starch (maize starch), NF; croscarmellose sodium, NF; Opadry white; Opacode Blue. Opadry white contains hypromellose, titanium dioxide, polyethylene glycol 400 and Opacode blue contains shellac, FD&C Blue #1, N-butyl alcohol, titanium dioxide, propylene glycol, isopropyl alcohol. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula. The empirical formula is C15H22O3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58°–61° C. Gemfibrozil is a white solid which is stable under ordinary conditions.</Description>
</NDC>
<NDC>
<NDCCode>75834-131-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (75834-131-60) </PackageDescription>
<NDC11Code>75834-0131-60</NDC11Code>
<ProductNDC>75834-131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gemfibrozil</ProprietaryName>
<NonProprietaryName>Gemfibrozil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203266</ApplicationNumber>
<LabelerName>Nivagen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GEMFIBROZIL</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for: 1 Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia., 2 Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL-and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY.</IndicationAndUsage>
<Description>Gemfibrozil tablets, USP 600 mg is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains calcium stearate, NF; microcrystalline cellulose, NF; hydroxypropyl cellulose, NF; polysorbate 80, NF; colloidal silicon dioxide, NF; pregelatinized starch (maize starch), NF; croscarmellose sodium, NF; Opadry white; Opacode Blue. Opadry white contains hypromellose, titanium dioxide, polyethylene glycol 400 and Opacode blue contains shellac, FD&C Blue #1, N-butyl alcohol, titanium dioxide, propylene glycol, isopropyl alcohol. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula. The empirical formula is C15H22O3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58°–61° C. Gemfibrozil is a white solid which is stable under ordinary conditions.</Description>
</NDC>
<NDC>
<NDCCode>45865-131-18</NDCCode>
<PackageDescription>18 TABLET, FILM COATED in 1 BLISTER PACK (45865-131-18) </PackageDescription>
<NDC11Code>45865-0131-18</NDC11Code>
<ProductNDC>45865-131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin Dihydrate</ProprietaryName>
<NonProprietaryName>Azithromycin Dihydrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208250</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>Azithromycin Tablets, USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranos yl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38H 72N 2O 12, and its molecular weight is 749.00. Azithromycin has the following structural formula:. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 12∙2H 2O and a molecular weight of 785.0. Azithromycin is supplied as tablets containing azithromycin dihydrate equivalent to 250 mg azithromycin and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Blue #1 aluminum lake and lecithin, FD&C Red #40 aluminum Lake, FD&C Yellow #6 aluminum Lake, macrogol/PEG, magnesium stearate, polyvinyl alcohol, pregelatinized starch, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>49035-131-89</NDCCode>
<PackageDescription>18 BLISTER PACK in 1 CARTON (49035-131-89) > 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>49035-0131-89</NDC11Code>
<ProductNDC>49035-131</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equate Suphedrine Pe</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140321</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Wal-Mart Stores Inc</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-03-14</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>53943-131-02</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (53943-131-02) / 18 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>53943-0131-02</NDC11Code>
<ProductNDC>53943-131</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Suphedrine Pe</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111206</StartMarketingDate>
<EndMarketingDate>20250831</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>DISCOUNT DRUG MART</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20111206</StartMarketingDatePackage>
<EndMarketingDatePackage>20250228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and nasal congestion associated with sinusitis. temporarily relieves sinus congestion and pressure.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53943-131-03</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (53943-131-03) / 18 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>53943-0131-03</NDC11Code>
<ProductNDC>53943-131</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Suphedrine Pe</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111206</StartMarketingDate>
<EndMarketingDate>20250831</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>DISCOUNT DRUG MART</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20111206</StartMarketingDatePackage>
<EndMarketingDatePackage>20250831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and nasal congestion associated with sinusitis. temporarily relieves sinus congestion and pressure.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54555-131-02</NDCCode>
<PackageDescription>18.9 L in 1 JUG (54555-131-02) </PackageDescription>
<NDC11Code>54555-0131-02</NDC11Code>
<ProductNDC>54555-131</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alco-gel</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Brainerd Chemical Company Inc.,</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-10-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>57344-131-02</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (57344-131-02) > 18 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>57344-0131-02</NDC11Code>
<ProductNDC>57344-131</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121222</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>AAA Pharmaceutical, Inc.</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>57344-131-03</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (57344-131-03) / 18 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>57344-0131-03</NDC11Code>
<ProductNDC>57344-131</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120413</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>AAA Pharmaceutical, Inc.</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120413</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and nasal congestion associated with sinusitis. temporarily relieves sinus congestion and pressure.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57344-131-04</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (57344-131-04) > 18 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>57344-0131-04</NDC11Code>
<ProductNDC>57344-131</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121222</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>AAA Pharmaceutical, Inc.</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58575-131-18</NDCCode>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dermagel Clear</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210503</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Inopak. Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-08-31</LastUpdate>
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<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<ProductNDC>61504-131</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sinus Congestion Pe</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231030</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>AMERIFOODS TRADING COMPANY</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-06</LastUpdate>
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<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves sinus congestion and pressure. temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies.</IndicationAndUsage>
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<NDC>
<NDCCode>70010-131-26</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (70010-131-26) / 18 TABLET in 1 BOTTLE</PackageDescription>
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<ProductNDC>70010-131</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen And Ibuprofen</ProprietaryName>
<NonProprietaryName>Acetaminophen And Ibuprofen</NonProprietaryName>
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<StartMarketingDate>20230724</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216592</ApplicationNumber>
<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; IBUPROFEN</SubstanceName>
<StrengthNumber>250; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-12</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>70038-131-81</NDCCode>
<PackageDescription>18 TABLET in 1 BOTTLE (70038-131-81) </PackageDescription>
<NDC11Code>70038-0131-81</NDC11Code>
<ProductNDC>70038-131</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216592</ApplicationNumber>
<LabelerName>RAONBIO CORP</LabelerName>
<SubstanceName>ACETAMINOPHEN; IBUPROFEN</SubstanceName>
<StrengthNumber>250; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ temporarily relieves minor aches and pains due to: ■ headache ■ toothache ■ backache ■ menstrual cramps ■ muscular aches ■ minor pain of arthritis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71919-821-18</NDCCode>
<PackageDescription>50 VIAL, GLASS in 1 KIT (71919-821-18) / 1 KIT in 1 VIAL, GLASS (71919-821-01) * 750 PELLET in 1 VIAL, GLASS (68428-127-01) * 750 PELLET in 1 VIAL, GLASS (68428-124-01) * 750 PELLET in 1 VIAL, GLASS (68428-123-01) * 750 PELLET in 1 VIAL, GLASS (68428-122-01) * 750 PELLET in 1 VIAL, GLASS (68428-119-01) * 750 PELLET in 1 VIAL, GLASS (68428-146-01) * 750 PELLET in 1 VIAL, GLASS (68428-099-01) * 750 PELLET in 1 VIAL, GLASS (68428-098-01) * 750 PELLET in 1 VIAL, GLASS (68428-097-01) * 750 PELLET in 1 VIAL, GLASS (68428-144-01) * 750 PELLET in 1 VIAL, GLASS (68428-142-01) * 750 PELLET in 1 VIAL, GLASS (68428-148-01) * 750 PELLET in 1 VIAL, GLASS (68428-147-01) * 750 PELLET in 1 VIAL, GLASS (68428-105-01) * 750 PELLET in 1 VIAL, GLASS (68428-104-01) * 750 PELLET in 1 VIAL, GLASS (68428-103-01) * 750 PELLET in 1 VIAL, GLASS (68428-102-01) * 350 PELLET in 1 VIAL, GLASS (71919-768-01) * 750 PELLET in 1 VIAL, GLASS (68428-101-01) * 750 PELLET in 1 VIAL, GLASS (68428-154-01) * 750 PELLET in 1 VIAL, GLASS (68428-112-01) * 750 PELLET in 1 VIAL, GLASS (68428-111-01) * 750 PELLET in 1 VIAL, GLASS (68428-109-01) * 750 PELLET in 1 VIAL, GLASS (68428-108-01) * 750 PELLET in 1 VIAL, GLASS (68428-107-01) * 750 PELLET in 1 VIAL, GLASS (68428-106-01) * 750 PELLET in 1 VIAL, GLASS (68428-149-01) * 750 PELLET in 1 VIAL, GLASS (68428-118-01) * 750 PELLET in 1 VIAL, GLASS (68428-117-01) * 750 PELLET in 1 VIAL, GLASS (68428-115-01) * 750 PELLET in 1 VIAL, GLASS (68428-156-01) * 750 PELLET in 1 VIAL, GLASS (68428-114-01) * 750 PELLET in 1 VIAL, GLASS (68428-155-01) * 750 PELLET in 1 VIAL, GLASS (68428-086-01) * 750 PELLET in 1 VIAL, GLASS (68428-095-01) * 750 PELLET in 1 VIAL, GLASS (68428-138-01) * 750 PELLET in 1 VIAL, GLASS (68428-092-01) * 750 PELLET in 1 VIAL, GLASS (68428-091-01) * 750 PELLET in 1 VIAL, GLASS (68428-085-01) * 750 PELLET in 1 VIAL, GLASS (68428-090-01) * 750 PELLET in 1 VIAL, GLASS (68428-134-01) * 750 PELLET in 1 VIAL, GLASS (68428-133-01) * 750 PELLET in 1 VIAL, GLASS (68428-084-01) * 750 PELLET in 1 VIAL, GLASS (68428-083-01) * 750 PELLET in 1 VIAL, GLASS (68428-082-01) * 750 PELLET in 1 VIAL, GLASS (68428-080-01) * 750 PELLET in 1 VIAL, GLASS (68428-131-01) * 750 PELLET in 1 VIAL, GLASS (68428-078-01) * 750 PELLET in 1 VIAL, GLASS (68428-125-01) * 750 PELLET in 1 VIAL, GLASS (68428-077-01) </PackageDescription>
<NDC11Code>71919-0821-18</NDC11Code>
<ProductNDC>71919-821</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>30c Homeopathic Remedy Kit</ProprietaryName>
<NonProprietaryName>50 Remedy Kit</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240221</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acon nap fear. Aesculus hipp hemorrhoids. Allium cepa head cold. Antimon crud warts. Apis mel stings. Arnica bruises. Arsenicum alb vomiting. Belladonna fever. Bellis bruised soreness. Berber vulg itching. Bryonia worse motion. Calc carb overwork. Caulophyllum cramps. Causticum hoarseness. Chamomilla irritability. Cimicifuga minor back pain. Coffea cruda sleeplessness. Drosera cough. Eupatorium perf flu-like symptoms. Euphrasia eye irritation. Ferrum phos low fever. Gelsemium lethargy. Hamamelis varicose veins. Hepar sulph calc croupiness. Hydrastis sinuses. Hypericum shooting pain. Ignatia sadness. Ipecac nausea. Kali bic sinuses. Kali carb sour belching. Kali mur congested ears. Kali phos irritability. Lachesis sore throat. Ledum black eyes. Lycopodium digestion. Mag phos cramps. Nat mur sneezing. Nux vom vomiting. Petroleum nausea. Phosphoricum ac headache. Phytolacca sore throat. Podoph pelt diarrhea. Pulsatilla weeping. Rhus tox better motion. Ruta bruised feeling. Sepia indifference. Staphysag anger. Sulphur skin problems. Symphytum prickling pain. Thuja occ warts.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72036-131-02</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (72036-131-02) / 18 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>72036-0131-02</NDC11Code>
<ProductNDC>72036-131</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Congestion Pe</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130611</StartMarketingDate>
<EndMarketingDate>20250831</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Harris Teeter</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130611</StartMarketingDatePackage>
<EndMarketingDatePackage>20250831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and nasal congestion associated with sinusitis. temporarily relieves sinus congestion and pressure.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72036-131-03</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (72036-131-03) / 18 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>72036-0131-03</NDC11Code>
<ProductNDC>72036-131</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Congestion Pe</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130611</StartMarketingDate>
<EndMarketingDate>20250831</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Harris Teeter</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130611</StartMarketingDatePackage>
<EndMarketingDatePackage>20250831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and nasal congestion associated with sinusitis. temporarily relieves sinus congestion and pressure.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72476-131-81</NDCCode>
<PackageDescription>18 TABLET in 1 BOTTLE (72476-131-81) </PackageDescription>
<NDC11Code>72476-0131-81</NDC11Code>
<ProductNDC>72476-131</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen And Ibuprofen (nsaid)</ProprietaryName>
<NonProprietaryName>Acetaminophen And Ibuprofen (nsaid)</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230720</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216592</ApplicationNumber>
<LabelerName>RETAIL BUSINESS SERVICES,LLC</LabelerName>
<SubstanceName>IBUPROFEN; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>125; 250</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ temporarily relieves minor aches and pains due to: ■ headache ■ toothache ■ backache ■ menstrual cramps ■ muscular aches ■ minor pain of arthritis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75834-148-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (75834-148-30) </PackageDescription>
<NDC11Code>75834-0148-30</NDC11Code>
<ProductNDC>75834-148</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209695</ApplicationNumber>
<LabelerName>NIVAGEN PHARMACEUTICALS, INC.</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine tablets are indicated for the treatment of: 1 Major Depressive Disorder (MDD). The efficacy of fluoxetine in MDD was established in one 5-week trial, three 6-week trials, and one maintenance study in adults. The efficacy of fluoxetine was also established in two 8- to 9-week trials in pediatric patients 8 to 18 years of age [see Clinical Studies ( 14.1)]. , 2 Obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). The efficacy of fluoxetine in OCD was demonstrated in two 13-week trials in adults and one 13-week trial in pediatric patients 7 to 17 years of age [see Clinical Studies ( 14.2) ]. , 3 Binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa. The efficacy of fluoxetine in Bulimia Nervosa was demonstrated in two 8-week trials and one 16-week trial in adults [see Clinical Studies ( 14.3)]. , 4 Panic Disorder, with or without agoraphobia. The efficacy of fluoxetine in Panic Disorder was demonstrated in two 12-week trials in adults [see Clinical Studies ( 14.4)]. .</IndicationAndUsage>
<Description>Fluoxetine hydrochloride USP is a selective serotonin reuptake inhibitor for oral administration. It is designated(±)- N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each scored tablet contains fluoxetine hydrochloride USP equivalent to 60 mg (194 µmol) of fluoxetine. In addition, each scored tablet also contains the following inactive ingredients: corn starch, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>75834-294-01</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (75834-294-01) </PackageDescription>
<NDC11Code>75834-0294-01</NDC11Code>
<ProductNDC>75834-294</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erythromycin Ethylsuccinate</ProprietaryName>
<NonProprietaryName>Erythromycin Ethylsuccinate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216212</ApplicationNumber>
<LabelerName>Nivagen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ERYTHROMYCIN ETHYLSUCCINATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate for oral suspension and other antibacterial drugs, erythromycin ethylsuccinate for oral suspension 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 ethylsuccinate for oral suspension is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below: Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae, or 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 pneumoniae or Streptococcus pyogenes. Listeriosis caused by Listeria monocytogenes. 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. 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).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 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.Syphilis Caused by Treponema pallidum Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy.Erythromycins are indicated for the 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. 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.ProphylaxisPrevention of Initial Attacks of Rheumatic FeverPenicillin 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). Erythromycin is indicated for the treatment of penicillin-allergic patients.1 The therapeutic dose should be administered for 10 days.Prevention of Recurrent Attacks of Rheumatic FeverPenicillin 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 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. The base, the stearate salt are practically insoluble in water, freely soluble in acetone, in anhydrous ethanol and in methanol. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethyl succinate). The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Erythromycin ethylsuccinate for oral suspension, USP 200 mg/5 mL when reconstituted with water, forms a suspension containing erythromycin ethylsuccinate equivalent to 200 mg erythromycin per 5 mL (teaspoonful) or 100 mg per 2.5 mL (dropperful) with an appealing banana flavor. Erythromycin ethylsuccinate for oral suspension, USP 400 mg/5 mL when reconstituted with water, forms a suspension containing erythromycin ethylsuccinate equivalent to 400 mg of erythromycin per 5 mL (teaspoonful) with an appealing banana flavor. These products are intended primarily for pediatric use but can also be used in adults.Inactive IngredientsErythromycin ethylsuccinate for oral suspension, USP 200 mg/5 mL, Erythromycin ethylsuccinate for oral suspension, USP 400 mg/5 mL: Banana flavour, caster sugar N° 1 400, neelinatural plain caramel powder, polysorbate 80, sodium citrate and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>75834-295-01</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (75834-295-01) </PackageDescription>
<NDC11Code>75834-0295-01</NDC11Code>
<ProductNDC>75834-295</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erythromycin Ethylsuccinate</ProprietaryName>
<NonProprietaryName>Erythromycin Ethylsuccinate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216212</ApplicationNumber>
<LabelerName>Nivagen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ERYTHROMYCIN ETHYLSUCCINATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate for oral suspension and other antibacterial drugs, erythromycin ethylsuccinate for oral suspension 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 ethylsuccinate for oral suspension is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below: Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae, or 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 pneumoniae or Streptococcus pyogenes. Listeriosis caused by Listeria monocytogenes. 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. 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).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 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.Syphilis Caused by Treponema pallidum Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy.Erythromycins are indicated for the 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. 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.ProphylaxisPrevention of Initial Attacks of Rheumatic FeverPenicillin 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). Erythromycin is indicated for the treatment of penicillin-allergic patients.1 The therapeutic dose should be administered for 10 days.Prevention of Recurrent Attacks of Rheumatic FeverPenicillin 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 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. The base, the stearate salt are practically insoluble in water, freely soluble in acetone, in anhydrous ethanol and in methanol. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethyl succinate). The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Erythromycin ethylsuccinate for oral suspension, USP 200 mg/5 mL when reconstituted with water, forms a suspension containing erythromycin ethylsuccinate equivalent to 200 mg erythromycin per 5 mL (teaspoonful) or 100 mg per 2.5 mL (dropperful) with an appealing banana flavor. Erythromycin ethylsuccinate for oral suspension, USP 400 mg/5 mL when reconstituted with water, forms a suspension containing erythromycin ethylsuccinate equivalent to 400 mg of erythromycin per 5 mL (teaspoonful) with an appealing banana flavor. These products are intended primarily for pediatric use but can also be used in adults.Inactive IngredientsErythromycin ethylsuccinate for oral suspension, USP 200 mg/5 mL, Erythromycin ethylsuccinate for oral suspension, USP 400 mg/5 mL: Banana flavour, caster sugar N° 1 400, neelinatural plain caramel powder, polysorbate 80, sodium citrate and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>75834-338-01</NDCCode>
<PackageDescription>1 POWDER, FOR SOLUTION in 1 PACKET (75834-338-01) </PackageDescription>
<NDC11Code>75834-0338-01</NDC11Code>
<ProductNDC>75834-338</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Potassium</ProprietaryName>
<NonProprietaryName>Diclofenac Potassium</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217010</ApplicationNumber>
<LabelerName>Nivagen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DICLOFENAC POTASSIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclofenac potassium for oral solution is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older). Limitations of Use: 1 Diclofenac potassium for oral solution is not indicated for the prophylactic therapy of migraine., 2 The safety and effectiveness of diclofenac potassium for oral solution have not been established for cluster headache, which is present in an older, predominantly male population.</IndicationAndUsage>
<Description>Diclofenac potassium for oral solution USP, 50 mg is a nonsteroidal anti-inflammatory drug, available as a buffered soluble powder, designed to be mixed with water prior to oral administration. Diclofenac potassium for oral solution USP, 50 mg is a white to off-white buffered, flavored powder for oral solution packaged in individual unit dose packets. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid monopotassium salt. The molecular weight is 334.25. Its molecular formula is C 14H 10Cl 2NKO 2, and it has the following structure. The inactive ingredients in diclofenac potassium for oral solution USP, 50 mg include: Potassium bicarbonate, glyceryl behenate, mannitol, natural peppermint flavor and sucralose.</Description>
</NDC>
<NDC>
<NDCCode>75834-338-02</NDCCode>
<PackageDescription>9 POWDER, FOR SOLUTION in 1 CARTON (75834-338-02) </PackageDescription>
<NDC11Code>75834-0338-02</NDC11Code>
<ProductNDC>75834-338</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Potassium</ProprietaryName>
<NonProprietaryName>Diclofenac Potassium</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217010</ApplicationNumber>
<LabelerName>Nivagen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DICLOFENAC POTASSIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclofenac potassium for oral solution is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older). Limitations of Use: 1 Diclofenac potassium for oral solution is not indicated for the prophylactic therapy of migraine., 2 The safety and effectiveness of diclofenac potassium for oral solution have not been established for cluster headache, which is present in an older, predominantly male population.</IndicationAndUsage>
<Description>Diclofenac potassium for oral solution USP, 50 mg is a nonsteroidal anti-inflammatory drug, available as a buffered soluble powder, designed to be mixed with water prior to oral administration. Diclofenac potassium for oral solution USP, 50 mg is a white to off-white buffered, flavored powder for oral solution packaged in individual unit dose packets. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid monopotassium salt. The molecular weight is 334.25. Its molecular formula is C 14H 10Cl 2NKO 2, and it has the following structure. The inactive ingredients in diclofenac potassium for oral solution USP, 50 mg include: Potassium bicarbonate, glyceryl behenate, mannitol, natural peppermint flavor and sucralose.</Description>
</NDC>
<NDC>
<NDCCode>42571-131-29</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (42571-131-29) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>42571-0131-29</NDC11Code>
<ProductNDC>42571-131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nevirapine</ProprietaryName>
<NonProprietaryName>Nevirapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120522</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203080</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>NEVIRAPINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nevirapine tablet is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older [see Clinical Studies (14.1, 14.2)] . Limitations of Use. Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine tablet is not recommended to be initiated, unless the benefit outweighs the risk, in: 1 adult females with CD4 +cell counts greater than 250 cells/mm 3or , 2 adult males with CD4 +cell counts greater than 400 cells/mm 3[see Warnings and Precautions (5.1)] . .</IndicationAndUsage>
<Description>Nevirapine tablets USP, 200 mg is the brand name for nevirapine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) with activity against Human Immunodeficiency Virus Type 1 (HIV-1). Nevirapine USP is structurally a member of the dipyridodiazepinone chemical class of compounds. The chemical name of nevirapine is 11-cyclopropyl-5, 11-dihydro-4-methyl-6H-dipyrido [3,2-b:2',3'-e][1,4] diazepin-6-one. Nevirapine USP is a white to off-white crystalline powder with the molecular weight of 266.30 and the molecular formula C 15H 14N 4O. Nevirapine has the following structural formula:. Nevirapine tablets USP, 200 mg is for oral administration. Each tablet contains 200 mg of nevirapine anhydrous and the inactive ingredients microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, magnesium stearate, povidone, and Sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>42571-131-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (42571-131-60) </PackageDescription>
<NDC11Code>42571-0131-60</NDC11Code>
<ProductNDC>42571-131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nevirapine</ProprietaryName>
<NonProprietaryName>Nevirapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120522</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203080</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>NEVIRAPINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nevirapine tablet is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older [see Clinical Studies (14.1, 14.2)] . Limitations of Use. Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine tablet is not recommended to be initiated, unless the benefit outweighs the risk, in: 1 adult females with CD4 +cell counts greater than 250 cells/mm 3or , 2 adult males with CD4 +cell counts greater than 400 cells/mm 3[see Warnings and Precautions (5.1)] . .</IndicationAndUsage>
<Description>Nevirapine tablets USP, 200 mg is the brand name for nevirapine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) with activity against Human Immunodeficiency Virus Type 1 (HIV-1). Nevirapine USP is structurally a member of the dipyridodiazepinone chemical class of compounds. The chemical name of nevirapine is 11-cyclopropyl-5, 11-dihydro-4-methyl-6H-dipyrido [3,2-b:2',3'-e][1,4] diazepin-6-one. Nevirapine USP is a white to off-white crystalline powder with the molecular weight of 266.30 and the molecular formula C 15H 14N 4O. Nevirapine has the following structural formula:. Nevirapine tablets USP, 200 mg is for oral administration. Each tablet contains 200 mg of nevirapine anhydrous and the inactive ingredients microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, magnesium stearate, povidone, and Sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>51862-571-30</NDCCode>
<PackageDescription>30 TABLET, DELAYED RELEASE in 1 BOTTLE (51862-571-30) </PackageDescription>
<NDC11Code>51862-0571-30</NDC11Code>
<ProductNDC>51862-571</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201002</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA050795</ApplicationNumber>
<LabelerName>Mayne Pharma Commercial LLC</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: 1 Rickettsial infections (1.1), 2 Sexually transmitted infections (1.2), 3 Respiratory tract infections (1.3), 4 Specific bacterial infections (1.4), 5 Ophthalmic infections (1.5), 6 Anthrax, including inhalational anthrax (post-exposure) (1.6), 7 Alternative treatment for selected infections when penicillin is contraindicated (1.7), 8 Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8), 9 Prophylaxis of malaria (1.9).</IndicationAndUsage>
<Description>Doxycycline hyclate delayed-release tablets, contain specially coated pellets of doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration. The structural formula for doxycycline hyclate is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6- methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 50 mg, 75 mg, 80 mg, 100 mg, 150 mg or 200 mg (equivalent to doxycycline hyclate 57.7 mg, 86.6 mg, 92.3 mg, 115.4 mg, 173.1 mg or 230.8 mg). Inactive ingredients in the tablet formulation are: lactose monohydrate; microcrystalline cellulose; sodium lauryl sulfate; sodium chloride; talc; anhydrous lactose; corn starch; crospovidone; magnesium stearate; cellulosic polymer coating. Each doxycycline hyclate delayed-release tablets 50 mg tablet contains 3 mg (0.131 mEq) of sodium, each doxycycline hyclate delayed-release tablets 75 mg tablet contains 4.5 mg (0.196 mEq) of sodium, each doxycycline hyclate delayed-release tablets 80 mg tablet contains 4.8 mg (0.209 mEq) of sodium, each doxycycline hyclate delayed-release tablets 100 mg tablet contains 6 mg (0.261 mEq) of sodium, each doxycycline hyclate delayed-release tablets 150 mg tablet contains 9 mg (0.392 mEq) of sodium, and each doxycycline hyclate delayed-release tablets 200 mg tablet contains 12 mg (0.522 mEq) of sodium.</Description>
</NDC>
<NDC>
<NDCCode>55292-131-60</NDCCode>
<PackageDescription>60 PACKAGE in 1 BOX (55292-131-60) / 6 AMPULE in 1 PACKAGE (55292-131-06) / 1 mL in 1 AMPULE (55292-131-01) </PackageDescription>
<NDC11Code>55292-0131-60</NDC11Code>
<ProductNDC>55292-131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Signifor</ProprietaryName>
<NonProprietaryName>Pasireotide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20121214</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200677</ApplicationNumber>
<LabelerName>Recordati Rare Diseases, Inc.</LabelerName>
<SubstanceName>PASIREOTIDE</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SIGNIFOR is a somatostatin analog indicated for the treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative (1).</IndicationAndUsage>
<Description>SIGNIFOR (pasireotide) injection is prepared as a sterile solution of pasireotide diaspartate in a tartaric acid buffer for administration by subcutaneous injection. SIGNIFOR is a somatostatin analog. Pasireotide diaspartate, chemically known as (2-Aminoethyl) carbamic acid (2R,5S,8S,11S,14R,17S,19aS)-11-(4-aminobutyl)-5-benzyl-8-(4-benzyloxybenzyl)-14-(1H-indol-3-ylmethyl)-4,7,10,13,16,19-hexaoxo-17-phenyloctadecahydro-3a,6,9,12,15,18-hexaazacyclopentacyclooctadecen-2-yl ester, di[(S)-2-aminosuccinic acid] salt, is a cyclohexapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin. The molecular formula of pasireotide diaspartate is C58H66N10O9 2 C4H7NO4 and the molecular weight is 1313.41 g/mol. The structural formula is. SIGNIFOR is supplied as a sterile solution in a single-dose, 1 mL colorless glass ampule containing pasireotide in 0.3 mg/mL, 0.6 mg/mL, or 0.9 mg/mL strengths for subcutaneous injection. Each glass ampule contains.</Description>
</NDC>
<NDC>
<NDCCode>57627-131-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (57627-131-02) > 30 mL in 1 BOTTLE (57627-131-01) </PackageDescription>
<NDC11Code>57627-0131-02</NDC11Code>
<ProductNDC>57627-131</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Desert Beige Perfecting Makeup Spf 25</ProprietaryName>
<ProprietaryNameSuffix>Merle Norman</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120822</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Merle Norman Cosmetics, Inc</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>2.25; 2.13</StrengthNumber>
<StrengthUnit>g/30mL; g/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>