{
"NDC": [
{
"NDCCode": "70771-1118-7",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (70771-1118-7) / 7 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "70771-1118-07",
"ProductNDC": "70771-1118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zypitamag",
"NonProprietaryName": "Pitavastatin Magnesium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180309",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208379",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "PITAVASTATIN",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180309",
"SamplePackage": "N"
},
{
"NDCCode": "55714-1118-0",
"PackageDescription": "7.08 g in 1 BOTTLE, GLASS (55714-1118-0)",
"NDC11Code": "55714-1118-00",
"ProductNDC": "55714-1118",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Jet Lag",
"NonProprietaryName": "Alumina, Aralia Quinquefolia, Arg. Nit., Arnica, Arsenicum Alb., Baptisia, Bryonia, Cantharis, Chelidonium Majus, Conium, Gelsemium, Iodium, Kali Carb., Kali Iod., Lycopodium, Lycopus Virginicus, Nat. Mur., Nux Vom., Phosphorus, Phytolacca, Pulsatilla, Rhus Toxicodendron, Sabal, Thyroidinum, Echinacea",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ALUMINUM OXIDE; AMERICAN GINSENG; SILVER NITRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IODINE; POTASSIUM CARBONATE; POTASSIUM IODIDE; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAW PALMETTO; THYROID, UNSPECIFIED; ECHINACEA, UNSPECIFIED",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_M]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Jet Lag Formulated for symptoms associated with travel such as fatigue, insomnia, headaches and digestive discomfort."
},
{
"NDCCode": "55714-1118-2",
"PackageDescription": "56.7 g in 1 BOTTLE, GLASS (55714-1118-2)",
"NDC11Code": "55714-1118-02",
"ProductNDC": "55714-1118",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Jet Lag",
"NonProprietaryName": "Alumina, Aralia Quinquefolia, Arg. Nit., Arnica, Arsenicum Alb., Baptisia, Bryonia, Cantharis, Chelidonium Majus, Conium, Gelsemium, Iodium, Kali Carb., Kali Iod., Lycopodium, Lycopus Virginicus, Nat. Mur., Nux Vom., Phosphorus, Phytolacca, Pulsatilla, Rhus Toxicodendron, Sabal, Thyroidinum, Echinacea",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ALUMINUM OXIDE; AMERICAN GINSENG; SILVER NITRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IODINE; POTASSIUM CARBONATE; POTASSIUM IODIDE; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAW PALMETTO; THYROID, UNSPECIFIED; ECHINACEA, UNSPECIFIED",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_M]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Jet Lag Formulated for symptoms associated with travel such as fatigue, insomnia, headaches and digestive discomfort."
},
{
"NDCCode": "71335-1118-7",
"PackageDescription": "90 TABLET in 1 BOTTLE (71335-1118-7) ",
"NDC11Code": "71335-1118-07",
"ProductNDC": "71335-1118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methotrexate",
"NonProprietaryName": "Methotrexate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19920518",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA081235",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "METHOTREXATE SODIUM",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240517",
"SamplePackage": "N",
"IndicationAndUsage": "Methotrexate tablets are a dihydrofolate reductase inhibitor indicated for the: : 1 Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen (1.1) , 2 Treatment of adults with mycosis fungoides (1.1) , 3 Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen (1.1) , 4 Treatment of adults with rheumatoid arthritis (1.2) , 5 Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) (1.3) , 6 Treatment of adults with severe psoriasis (1.4) .",
"Description": "Methotrexate is dihydrofolate reductase inhibitor with the chemical name of N-[4-[[(2,4 diamino-6-pteridinyl) methyl]methylamino]benzoyl]-L glutamic acid. The molecular formula is C20H22N8O5 and the molecular weight is 454.4 g/mol. The structural formula is. Methotrexate Tablets, USP for oral use are available in bottles of 100 tablets. Each methotrexate tablet contains 2.5 mg methotrexate equivalent to 2.74 mg methotrexate sodium and the following inactive ingredients: colloidal silicon dioxide, FD&C Red No. 40 Aluminum Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), sodium carbonate (monohydrate), sodium lauryl sulfate and sodium starch glycolate (potato)."
},
{
"NDCCode": "70771-1118-0",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (70771-1118-0) ",
"NDC11Code": "70771-1118-00",
"ProductNDC": "70771-1118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zypitamag",
"NonProprietaryName": "Pitavastatin Magnesium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180309",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208379",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "PITAVASTATIN",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180309",
"SamplePackage": "N"
},
{
"NDCCode": "70771-1118-1",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (70771-1118-1) ",
"NDC11Code": "70771-1118-01",
"ProductNDC": "70771-1118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zypitamag",
"NonProprietaryName": "Pitavastatin Magnesium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180309",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208379",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "PITAVASTATIN",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180309",
"SamplePackage": "N"
},
{
"NDCCode": "70771-1118-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70771-1118-3) ",
"NDC11Code": "70771-1118-03",
"ProductNDC": "70771-1118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zypitamag",
"NonProprietaryName": "Pitavastatin Magnesium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180309",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208379",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "PITAVASTATIN",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180309",
"SamplePackage": "N"
},
{
"NDCCode": "70771-1118-4",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70771-1118-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "70771-1118-04",
"ProductNDC": "70771-1118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zypitamag",
"NonProprietaryName": "Pitavastatin Magnesium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180309",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208379",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "PITAVASTATIN",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180309",
"SamplePackage": "N"
},
{
"NDCCode": "70771-1118-5",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (70771-1118-5) ",
"NDC11Code": "70771-1118-05",
"ProductNDC": "70771-1118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zypitamag",
"NonProprietaryName": "Pitavastatin Magnesium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180309",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208379",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "PITAVASTATIN",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180309",
"SamplePackage": "N"
},
{
"NDCCode": "70771-1118-9",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (70771-1118-9) ",
"NDC11Code": "70771-1118-09",
"ProductNDC": "70771-1118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zypitamag",
"NonProprietaryName": "Pitavastatin Magnesium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180309",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208379",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "PITAVASTATIN",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180309",
"SamplePackage": "N"
},
{
"NDCCode": "0463-1118-11",
"PackageDescription": "10 VIAL in 1 CARTON (0463-1118-11) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0463-1118-10)",
"NDC11Code": "00463-1118-11",
"ProductNDC": "0463-1118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin",
"NonProprietaryName": "Ampicillin Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20091228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090354",
"LabelerName": "C.O. Truxton, Inc.",
"SubstanceName": "AMPICILLIN SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions. Respiratory tract Infections caused by S. pneumoniae (formerly D. pneumoniae). Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic Streptococci. Bacterial Meningitis caused by E. coli, Group B Streptococci, and other Gram-negative bacteria (Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus sp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella sp. respond to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptoccoccal endocarditis. Urinary Tract Infections caused by sensitve strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhosa (typhoid fever), other Salmonella sp., and Shigella sp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP 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. Indicated surgical procedures should be performed.",
"Description": "Ampicillin for Injection, USP the monosodium salt of [2S-[2α,5α,6β(S*)]]-6-[(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. It has the following chemical structure. Ampicillin sodium is a white to off-white crystalline powder with the molecular formula of C16H18N3NaO4S, and the molecular weight of 371.39. Each vial of Ampicillin for Injection contains ampicillin sodium equivalent to 1 gram ampicillin. Ampicillin for Injection, USP contains 2.9 milliequivalents of sodium (66 mg of sodium) per 1 gram of drug."
},
{
"NDCCode": "10742-1118-1",
"PackageDescription": "1 POUCH in 1 CARTON (10742-1118-1) / 5 PATCH in 1 POUCH",
"NDC11Code": "10742-1118-01",
"ProductNDC": "10742-1118",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold And Hot Medicated",
"NonProprietaryName": "Menthol",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "The Mentholatum Company",
"SubstanceName": "MENTHOL, UNSPECIFIED FORM",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141201",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains of muscles and joints due to: 1 arthritis , 2 simple backache , 3 strains , 4 sprains , 5 bursitis , 6 tendonitis , 7 bruises , 8 cramps ."
},
{
"NDCCode": "67939-010-50",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (67939-010-50) ",
"NDC11Code": "67939-0010-50",
"ProductNDC": "67939-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fludeoxyglucose F 18",
"NonProprietaryName": "Fludeoxyglucose F 18",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20131101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204498",
"LabelerName": "The University of Utah DBA Cyclotron Radiochemistry Lab / Huntsman Cancer Institute",
"SubstanceName": "FLUDEOXYGLUCOSE F-18",
"StrengthNumber": "300",
"StrengthUnit": "mCi/mL",
"Pharm_Classes": "Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]",
"Status": "Active",
"LastUpdate": "2022-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200520",
"SamplePackage": "N",
"IndicationAndUsage": "Fludeoxyglucose F-18 Injection, USP is indicated for positron emission tomography (PET) imaging in the following settings.",
"Description": "Fludeoxyglucose F-18 Injection, USP is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with positron emission tomography (PET) imaging. The active ingredient 2-deoxy-2-[ 18F]fluoro-D-glucose has the molecular formula of C 6H 1118 FO 5 with a molecular weight of 181.26, and has the following chemical structure:. Fludeoxyglucose F-18 Injection, USP is provided as a ready to use sterile, pyrogen free, clear, colorless citrate buffered solution. Each mL contains between 0.740 to 11.1GBq (20.0-300 mCi) of 2-deoxy-2- [ 18F]fluoro-D-glucose at the EOS, 4.5 mg of sodium chloride in citrate buffer. The pH of the solution is between 4.5 and 7.5. The solution is packaged in a multiple-dose glass vial and does not contain any preservative."
},
{
"NDCCode": "69238-1118-1",
"PackageDescription": "100 TABLET in 1 BOTTLE (69238-1118-1) ",
"NDC11Code": "69238-1118-01",
"ProductNDC": "69238-1118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hcl",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208829",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170524",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge,\" irritability, impatience.",
"Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2 HCl is represented by the following structural formula. Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "69238-1118-2",
"PackageDescription": "180 TABLET in 1 BOTTLE (69238-1118-2) ",
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"ProductNDC": "69238-1118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hcl",
"NonProprietaryName": "Buspirone Hydrochloride",
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"RouteName": "ORAL",
"StartMarketingDate": "20170524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208829",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-12-04",
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"StartMarketingDatePackage": "20170524",
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"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge,\" irritability, impatience.",
"Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2 HCl is represented by the following structural formula. Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "69238-1118-5",
"PackageDescription": "500 TABLET in 1 BOTTLE (69238-1118-5) ",
"NDC11Code": "69238-1118-05",
"ProductNDC": "69238-1118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hcl",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208829",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20170524",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge,\" irritability, impatience.",
"Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2 HCl is represented by the following structural formula. Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "69238-1118-6",
"PackageDescription": "60 TABLET in 1 BOTTLE (69238-1118-6) ",
"NDC11Code": "69238-1118-06",
"ProductNDC": "69238-1118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hcl",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208829",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge,\" irritability, impatience.",
"Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2 HCl is represented by the following structural formula. Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
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"ProductNDC": "76519-1118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tetracaine Hydrochloride",
"NonProprietaryName": "Tetracaine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
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"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "H.J. Harkins Company, Inc.",
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"Pharm_Classes": "Esters [CS],Local Anesthesia [PE],Ester Local Anesthetic [EPC]",
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"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20160128",
"SamplePackage": "N",
"IndicationAndUsage": "For procedures in which a rapid and short-acting topical ophthalmic anesthetic is indicated such as in tonometry, gonioscopy, removal of corneal foreign bodies, conjunctival scraping for diagnostic purposes, suture removal from the cornea, other short corneal and conjunctival procedures.",
"Description": "Tetracaine Hydrochloride is a sterile aqueous topical anesthetic ophthalmic solution. The active ingredient is represented by the chemical structure. C15H24N2O2·HCI Mol. wt. 300.83. Benzoic acid, 4-[butylamino]-, 2-[dimethylamino]ethyl ester, monohydrochloride. EACH mL CONTAINS: ACTIVE: Tetracaine Hydrochloride 5 mg (0.5%); INACTIVES: Boric Acid, Potassium Chloride, Edetate Disodium and Purified Water. Sodium Hydroxide and/or Hydrochloric Acid may be added to adjust pH (3.7 - 6.0). PRESERVATIVE ADDED: Chlorobutanol 0.4%."
},
{
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"PackageDescription": "118.29 mL in 1 BOTTLE (78046-1118-1) ",
"NDC11Code": "78046-1118-01",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer Gel",
"NonProprietaryName": "Alcohol",
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"LabelerName": "Hill & Markes",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
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"PackageNdcExcludeFlag": "N",
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},
{
"NDCCode": "70771-1008-7",
"PackageDescription": "50 TABLET, FILM COATED in 1 BOTTLE (70771-1008-7) ",
"NDC11Code": "70771-1008-07",
"ProductNDC": "70771-1008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline",
"NonProprietaryName": "Doxycycline",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209582",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "DOXYCYCLINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180111",
"SamplePackage": "N"
},
{
"NDCCode": "70771-1010-8",
"PackageDescription": "2 CARTON in 1 CARTON (70771-1010-8) / 1 BLISTER PACK in 1 CARTON (70771-1010-7) / 14 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "70771-1010-08",
"ProductNDC": "70771-1010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teriflunomide",
"NonProprietaryName": "Teriflunomide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209668",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "TERIFLUNOMIDE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230214",
"SamplePackage": "N"
},
{
"NDCCode": "70771-1011-8",
"PackageDescription": "2 CARTON in 1 CARTON (70771-1011-8) / 1 BLISTER PACK in 1 CARTON (70771-1011-7) / 14 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "70771-1011-08",
"ProductNDC": "70771-1011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teriflunomide",
"NonProprietaryName": "Teriflunomide",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209668",
"LabelerName": "Zydus Lifesciences Limited",
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"StrengthNumber": "14",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230214",
"SamplePackage": "N"
},
{
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"PackageDescription": "30 CAPSULE in 1 BOTTLE (70771-1012-7) ",
"NDC11Code": "70771-1012-07",
"ProductNDC": "70771-1012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clomipramine Hydrochloride",
"NonProprietaryName": "Clomipramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180503",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208961",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "CLOMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
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"LastUpdate": "2025-04-03",
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"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180503",
"SamplePackage": "N"
},
{
"NDCCode": "70771-1013-7",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (70771-1013-7) ",
"NDC11Code": "70771-1013-07",
"ProductNDC": "70771-1013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clomipramine Hydrochloride",
"NonProprietaryName": "Clomipramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180503",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208961",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "CLOMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180503",
"SamplePackage": "N"
},
{
"NDCCode": "70771-1014-7",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (70771-1014-7) ",
"NDC11Code": "70771-1014-07",
"ProductNDC": "70771-1014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clomipramine Hydrochloride",
"NonProprietaryName": "Clomipramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180503",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208961",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "CLOMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180503",
"SamplePackage": "N"
},
{
"NDCCode": "70771-1046-7",
"PackageDescription": "50 TABLET in 1 BOTTLE (70771-1046-7) ",
"NDC11Code": "70771-1046-07",
"ProductNDC": "70771-1046",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206560",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
"Status": "Active",
"LastUpdate": "2024-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190223",
"SamplePackage": "N",
"IndicationAndUsage": "Symptomatic Trichomoniasis. Metronidazole tablets, USP are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets, USP are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with metronidazole tablets in cases of reinfection. Amebiasis. Metronidazole tablets, USP are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, metronidazole tablets therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole tablets, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole tablets therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets and other antibacterial drugs, metronidazole tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Metronidazole tablets, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula:. Metronidazole USP is a white to pale yellow, crystalline powder. It is sparingly soluble in water and alcohol; slightly soluble in ether and chloroform; soluble in dilute hydrochloric acid. Each metronidazole tablet, USP intended for oral administration contains 250 mg or 500 mg of metronidazole. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, low-substituted hydroxypropyl cellulose, microcrystalline cellulose and stearic acid. Additionally, each tablet contains opadry II white 02F580003 which contains hypromellose, polyethylene glycol, talc and titanium dioxide."
},
{
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"PackageDescription": "100 BLISTER PACK in 1 CARTON (70771-1058-7) / 1 TABLET in 1 BLISTER PACK (70771-1058-2) ",
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"ProductNDC": "70771-1058",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207812",
"LabelerName": "Zydus Lifesciences Limited",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
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"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20170209",
"SamplePackage": "N"
},
{
"NDCCode": "70771-1059-7",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70771-1059-7) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1059-2) ",
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"ProductNDC": "70771-1059",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil",
"NonProprietaryName": "Olmesartan Medoxomil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170424",
"MarketingCategoryName": "ANDA",
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"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "OLMESARTAN MEDOXOMIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
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"LastUpdate": "2025-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170424",
"SamplePackage": "N"
},
{
"NDCCode": "70771-1060-7",
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"ProductNDC": "70771-1060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil",
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"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205192",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "OLMESARTAN MEDOXOMIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170424",
"SamplePackage": "N"
},
{
"NDCCode": "70771-1061-7",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70771-1061-7) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1061-2) ",
"NDC11Code": "70771-1061-07",
"ProductNDC": "70771-1061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil",
"NonProprietaryName": "Olmesartan Medoxomil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170424",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205192",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "OLMESARTAN MEDOXOMIL",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170424",
"SamplePackage": "N"
}
]
}
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zypitamag</ProprietaryName>
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<PackageDescription>7.08 g in 1 BOTTLE, GLASS (55714-1118-0)</PackageDescription>
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<ProductNDC>55714-1118</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Jet Lag</ProprietaryName>
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<Status>Deprecated</Status>
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<NDC>
<NDCCode>55714-1118-2</NDCCode>
<PackageDescription>56.7 g in 1 BOTTLE, GLASS (55714-1118-2)</PackageDescription>
<NDC11Code>55714-1118-02</NDC11Code>
<ProductNDC>55714-1118</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<LabelerName>Newton Laboratories, Inc.</LabelerName>
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<Status>Deprecated</Status>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<NDC>
<NDCCode>71335-1118-7</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71335-1118-7) </PackageDescription>
<NDC11Code>71335-1118-07</NDC11Code>
<ProductNDC>71335-1118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methotrexate</ProprietaryName>
<NonProprietaryName>Methotrexate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920518</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA081235</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>METHOTREXATE SODIUM</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methotrexate tablets are a dihydrofolate reductase inhibitor indicated for the: : 1 Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen (1.1) , 2 Treatment of adults with mycosis fungoides (1.1) , 3 Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen (1.1) , 4 Treatment of adults with rheumatoid arthritis (1.2) , 5 Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) (1.3) , 6 Treatment of adults with severe psoriasis (1.4) .</IndicationAndUsage>
<Description>Methotrexate is dihydrofolate reductase inhibitor with the chemical name of N-[4-[[(2,4 diamino-6-pteridinyl) methyl]methylamino]benzoyl]-L glutamic acid. The molecular formula is C20H22N8O5 and the molecular weight is 454.4 g/mol. The structural formula is. Methotrexate Tablets, USP for oral use are available in bottles of 100 tablets. Each methotrexate tablet contains 2.5 mg methotrexate equivalent to 2.74 mg methotrexate sodium and the following inactive ingredients: colloidal silicon dioxide, FD&C Red No. 40 Aluminum Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), sodium carbonate (monohydrate), sodium lauryl sulfate and sodium starch glycolate (potato).</Description>
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<NDCCode>70771-1118-0</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (70771-1118-0) </PackageDescription>
<NDC11Code>70771-1118-00</NDC11Code>
<ProductNDC>70771-1118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zypitamag</ProprietaryName>
<NonProprietaryName>Pitavastatin Magnesium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180309</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208379</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>PITAVASTATIN</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70771-1118-1</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (70771-1118-1) </PackageDescription>
<NDC11Code>70771-1118-01</NDC11Code>
<ProductNDC>70771-1118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zypitamag</ProprietaryName>
<NonProprietaryName>Pitavastatin Magnesium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180309</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208379</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>PITAVASTATIN</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70771-1118-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70771-1118-3) </PackageDescription>
<NDC11Code>70771-1118-03</NDC11Code>
<ProductNDC>70771-1118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zypitamag</ProprietaryName>
<NonProprietaryName>Pitavastatin Magnesium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180309</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208379</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>PITAVASTATIN</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
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<NDCCode>70771-1118-4</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70771-1118-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70771-1118-04</NDC11Code>
<ProductNDC>70771-1118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zypitamag</ProprietaryName>
<NonProprietaryName>Pitavastatin Magnesium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180309</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208379</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>PITAVASTATIN</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70771-1118-5</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (70771-1118-5) </PackageDescription>
<NDC11Code>70771-1118-05</NDC11Code>
<ProductNDC>70771-1118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zypitamag</ProprietaryName>
<NonProprietaryName>Pitavastatin Magnesium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180309</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208379</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>PITAVASTATIN</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70771-1118-9</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (70771-1118-9) </PackageDescription>
<NDC11Code>70771-1118-09</NDC11Code>
<ProductNDC>70771-1118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zypitamag</ProprietaryName>
<NonProprietaryName>Pitavastatin Magnesium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180309</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208379</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>PITAVASTATIN</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0463-1118-11</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (0463-1118-11) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0463-1118-10)</PackageDescription>
<NDC11Code>00463-1118-11</NDC11Code>
<ProductNDC>0463-1118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin</ProprietaryName>
<NonProprietaryName>Ampicillin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20091228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090354</ApplicationNumber>
<LabelerName>C.O. Truxton, Inc.</LabelerName>
<SubstanceName>AMPICILLIN SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions. Respiratory tract Infections caused by S. pneumoniae (formerly D. pneumoniae). Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic Streptococci. Bacterial Meningitis caused by E. coli, Group B Streptococci, and other Gram-negative bacteria (Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus sp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella sp. respond to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptoccoccal endocarditis. Urinary Tract Infections caused by sensitve strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhosa (typhoid fever), other Salmonella sp., and Shigella sp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP 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. Indicated surgical procedures should be performed.</IndicationAndUsage>
<Description>Ampicillin for Injection, USP the monosodium salt of [2S-[2α,5α,6β(S*)]]-6-[(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. It has the following chemical structure. Ampicillin sodium is a white to off-white crystalline powder with the molecular formula of C16H18N3NaO4S, and the molecular weight of 371.39. Each vial of Ampicillin for Injection contains ampicillin sodium equivalent to 1 gram ampicillin. Ampicillin for Injection, USP contains 2.9 milliequivalents of sodium (66 mg of sodium) per 1 gram of drug.</Description>
</NDC>
<NDC>
<NDCCode>10742-1118-1</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (10742-1118-1) / 5 PATCH in 1 POUCH</PackageDescription>
<NDC11Code>10742-1118-01</NDC11Code>
<ProductNDC>10742-1118</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold And Hot Medicated</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>The Mentholatum Company</LabelerName>
<SubstanceName>MENTHOL, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains of muscles and joints due to: 1 arthritis , 2 simple backache , 3 strains , 4 sprains , 5 bursitis , 6 tendonitis , 7 bruises , 8 cramps .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>67939-010-50</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (67939-010-50) </PackageDescription>
<NDC11Code>67939-0010-50</NDC11Code>
<ProductNDC>67939-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fludeoxyglucose F 18</ProprietaryName>
<NonProprietaryName>Fludeoxyglucose F 18</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20131101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204498</ApplicationNumber>
<LabelerName>The University of Utah DBA Cyclotron Radiochemistry Lab / Huntsman Cancer Institute</LabelerName>
<SubstanceName>FLUDEOXYGLUCOSE F-18</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Pharm_Classes>Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fludeoxyglucose F-18 Injection, USP is indicated for positron emission tomography (PET) imaging in the following settings.</IndicationAndUsage>
<Description>Fludeoxyglucose F-18 Injection, USP is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with positron emission tomography (PET) imaging. The active ingredient 2-deoxy-2-[ 18F]fluoro-D-glucose has the molecular formula of C 6H 1118 FO 5 with a molecular weight of 181.26, and has the following chemical structure:. Fludeoxyglucose F-18 Injection, USP is provided as a ready to use sterile, pyrogen free, clear, colorless citrate buffered solution. Each mL contains between 0.740 to 11.1GBq (20.0-300 mCi) of 2-deoxy-2- [ 18F]fluoro-D-glucose at the EOS, 4.5 mg of sodium chloride in citrate buffer. The pH of the solution is between 4.5 and 7.5. The solution is packaged in a multiple-dose glass vial and does not contain any preservative.</Description>
</NDC>
<NDC>
<NDCCode>69238-1118-1</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (69238-1118-1) </PackageDescription>
<NDC11Code>69238-1118-01</NDC11Code>
<ProductNDC>69238-1118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hcl</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208829</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2 HCl is represented by the following structural formula. Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>69238-1118-2</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (69238-1118-2) </PackageDescription>
<NDC11Code>69238-1118-02</NDC11Code>
<ProductNDC>69238-1118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hcl</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208829</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2 HCl is represented by the following structural formula. Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>69238-1118-5</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (69238-1118-5) </PackageDescription>
<NDC11Code>69238-1118-05</NDC11Code>
<ProductNDC>69238-1118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hcl</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208829</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2 HCl is represented by the following structural formula. Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>69238-1118-6</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (69238-1118-6) </PackageDescription>
<NDC11Code>69238-1118-06</NDC11Code>
<ProductNDC>69238-1118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hcl</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208829</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2 HCl is represented by the following structural formula. Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>76519-1118-5</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE, DROPPER (76519-1118-5) </PackageDescription>
<NDC11Code>76519-1118-05</NDC11Code>
<ProductNDC>76519-1118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tetracaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Tetracaine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20160128</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>TETRACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Esters [CS],Local Anesthesia [PE],Ester Local Anesthetic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For procedures in which a rapid and short-acting topical ophthalmic anesthetic is indicated such as in tonometry, gonioscopy, removal of corneal foreign bodies, conjunctival scraping for diagnostic purposes, suture removal from the cornea, other short corneal and conjunctival procedures.</IndicationAndUsage>
<Description>Tetracaine Hydrochloride is a sterile aqueous topical anesthetic ophthalmic solution. The active ingredient is represented by the chemical structure. C15H24N2O2·HCI Mol. wt. 300.83. Benzoic acid, 4-[butylamino]-, 2-[dimethylamino]ethyl ester, monohydrochloride. EACH mL CONTAINS: ACTIVE: Tetracaine Hydrochloride 5 mg (0.5%); INACTIVES: Boric Acid, Potassium Chloride, Edetate Disodium and Purified Water. Sodium Hydroxide and/or Hydrochloric Acid may be added to adjust pH (3.7 - 6.0). PRESERVATIVE ADDED: Chlorobutanol 0.4%.</Description>
</NDC>
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<NDCCode>78046-1118-1</NDCCode>
<PackageDescription>118.29 mL in 1 BOTTLE (78046-1118-1) </PackageDescription>
<NDC11Code>78046-1118-01</NDC11Code>
<ProductNDC>78046-1118</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer Gel</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200721</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Hill & Markes</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200721</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70771-1008-7</NDCCode>
<PackageDescription>50 TABLET, FILM COATED in 1 BOTTLE (70771-1008-7) </PackageDescription>
<NDC11Code>70771-1008-07</NDC11Code>
<ProductNDC>70771-1008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<NonProprietaryName>Doxycycline</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209582</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>DOXYCYCLINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70771-1010-8</NDCCode>
<PackageDescription>2 CARTON in 1 CARTON (70771-1010-8) / 1 BLISTER PACK in 1 CARTON (70771-1010-7) / 14 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70771-1010-08</NDC11Code>
<ProductNDC>70771-1010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teriflunomide</ProprietaryName>
<NonProprietaryName>Teriflunomide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209668</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>TERIFLUNOMIDE</SubstanceName>
<StrengthNumber>7</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70771-1011-8</NDCCode>
<PackageDescription>2 CARTON in 1 CARTON (70771-1011-8) / 1 BLISTER PACK in 1 CARTON (70771-1011-7) / 14 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70771-1011-08</NDC11Code>
<ProductNDC>70771-1011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teriflunomide</ProprietaryName>
<NonProprietaryName>Teriflunomide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209668</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>TERIFLUNOMIDE</SubstanceName>
<StrengthNumber>14</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70771-1012-7</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (70771-1012-7) </PackageDescription>
<NDC11Code>70771-1012-07</NDC11Code>
<ProductNDC>70771-1012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clomipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clomipramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180503</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208961</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>CLOMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180503</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70771-1013-7</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (70771-1013-7) </PackageDescription>
<NDC11Code>70771-1013-07</NDC11Code>
<ProductNDC>70771-1013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clomipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clomipramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180503</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208961</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>CLOMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180503</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70771-1014-7</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (70771-1014-7) </PackageDescription>
<NDC11Code>70771-1014-07</NDC11Code>
<ProductNDC>70771-1014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clomipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clomipramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180503</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208961</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>CLOMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180503</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70771-1046-7</NDCCode>
<PackageDescription>50 TABLET in 1 BOTTLE (70771-1046-7) </PackageDescription>
<NDC11Code>70771-1046-07</NDC11Code>
<ProductNDC>70771-1046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole</ProprietaryName>
<NonProprietaryName>Metronidazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206560</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Symptomatic Trichomoniasis. Metronidazole tablets, USP are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets, USP are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with metronidazole tablets in cases of reinfection. Amebiasis. Metronidazole tablets, USP are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, metronidazole tablets therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole tablets, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole tablets therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets and other antibacterial drugs, metronidazole tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Metronidazole tablets, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula:. Metronidazole USP is a white to pale yellow, crystalline powder. It is sparingly soluble in water and alcohol; slightly soluble in ether and chloroform; soluble in dilute hydrochloric acid. Each metronidazole tablet, USP intended for oral administration contains 250 mg or 500 mg of metronidazole. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, low-substituted hydroxypropyl cellulose, microcrystalline cellulose and stearic acid. Additionally, each tablet contains opadry II white 02F580003 which contains hypromellose, polyethylene glycol, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70771-1058-7</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (70771-1058-7) / 1 TABLET in 1 BLISTER PACK (70771-1058-2) </PackageDescription>
<NDC11Code>70771-1058-07</NDC11Code>
<ProductNDC>70771-1058</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methotrexate</ProprietaryName>
<NonProprietaryName>Methotrexate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207812</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>METHOTREXATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70771-1059-7</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70771-1059-7) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1059-2) </PackageDescription>
<NDC11Code>70771-1059-07</NDC11Code>
<ProductNDC>70771-1059</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170424</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205192</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70771-1060-7</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70771-1060-7) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1060-2) </PackageDescription>
<NDC11Code>70771-1060-07</NDC11Code>
<ProductNDC>70771-1060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170424</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205192</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70771-1061-7</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70771-1061-7) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1061-2) </PackageDescription>
<NDC11Code>70771-1061-07</NDC11Code>
<ProductNDC>70771-1061</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170424</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205192</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
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