{
"NDC": [
{
"NDCCode": "67850-032-10",
"PackageDescription": "10 VIAL in 1 CARTON (67850-032-10) / 2 g in 1 VIAL",
"NDC11Code": "67850-0032-10",
"ProductNDC": "67850-032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nafcillin",
"NonProprietaryName": "Nafcillin Injection",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20190305",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090560",
"LabelerName": "Methapharm Inc.",
"SubstanceName": "NAFCILLIN SODIUM",
"StrengthNumber": "2",
"StrengthUnit": "g/2g",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190305",
"SamplePackage": "N",
"IndicationAndUsage": "Nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see CLINICAL PHARMACOLOGY - Susceptibility Test Methods). Nafcillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to methicillin resistant Staphylococcus sp., therapy with Nafcillin for Injection should be discontinued and alternative therapy provided. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nafcillin for Injection and other antibacterial drugs. Nafcillin for Injection 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": "Nafcillin for Injection, USP is semisynthetic penicillin derived from the penicillin nucleus,6-amino-penicillanic acid. The chemical name of nafcillin sodium is Monosodium (2S, 5R, 6R)-6-(2-ethoxy-1-naphthamido)-3, 3-dimethyl-7-oxo-4-thia-1- azabicyclo [3.2.0]heptane-2-carboxylate monohydrate. It is resistant to inactivation by the enzyme penicillinase (beta-lactamase). The structural formula of nafcillin sodium is as follows. C 21H 21N 2NaO 5S ●H 2O MW=454.47. Nafcillin for Injection, USP for the intramuscular or intravenous route of administration, contains nafacilin sodium as a sterile white to off-white crystalline dry powder for reconstitution. The reconstituted solution is a clear and colorless solution. The pH of the reconstituted solution is 6 - 8.5. Nafcillin for Injection, USP contains nafcillin sodium as the monohydrate equivalent to 1 gram or 2 grams of nafcillin per vial and is buffered with approximately 38 mg sodium citrate per gram. The sodium content is about 66 mg [2.9 mEq] per gram."
},
{
"NDCCode": "67850-021-10",
"PackageDescription": "10 VIAL in 1 PACKAGE (67850-021-10) / 1 g in 1 VIAL (67850-021-00) ",
"NDC11Code": "67850-0021-10",
"ProductNDC": "67850-021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin",
"NonProprietaryName": "Ampicillin Injection",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20190306",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090354",
"LabelerName": "Methapharm Inc.",
"SubstanceName": "AMPICILLIN SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190306",
"SamplePackage": "N",
"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 Infectionscaused by S treptococcus pneumoniae, Staphylococcus aureus(penicillinase and nonpenicillinase-producing), H. influenzae,and Group A beta-hemolytic Streptococci. Bacterial Meningitiscaused 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 Endocarditiscaused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds 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 streptococcal endocarditis. Urinary Tract Infectionscaused by sensitive strains of E. coliand P roteus mirabilis. Gastrointestinal Infectionscaused by Salmonella typhi(typhoid fever), other Salmonella spp., and Shigella spp. (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. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates. Each vial of Ampicillin for Injection, USP contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin. Ampicillin for Injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. It has the following molecular structure. The molecular formula is C 16H 18N 3NaO 4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10."
},
{
"NDCCode": "67850-022-10",
"PackageDescription": "10 VIAL in 1 PACKAGE (67850-022-10) / 2 g in 1 VIAL (67850-022-00) ",
"NDC11Code": "67850-0022-10",
"ProductNDC": "67850-022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin",
"NonProprietaryName": "Ampicillin Injection",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20190306",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090354",
"LabelerName": "Methapharm Inc.",
"SubstanceName": "AMPICILLIN SODIUM",
"StrengthNumber": "2",
"StrengthUnit": "g/2g",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190306",
"SamplePackage": "N",
"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 Infectionscaused by S treptococcus pneumoniae, Staphylococcus aureus(penicillinase and nonpenicillinase-producing), H. influenzae,and Group A beta-hemolytic Streptococci. Bacterial Meningitiscaused 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 Endocarditiscaused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds 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 streptococcal endocarditis. Urinary Tract Infectionscaused by sensitive strains of E. coliand P roteus mirabilis. Gastrointestinal Infectionscaused by Salmonella typhi(typhoid fever), other Salmonella spp., and Shigella spp. (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. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates. Each vial of Ampicillin for Injection, USP contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin. Ampicillin for Injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. It has the following molecular structure. The molecular formula is C 16H 18N 3NaO 4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10."
},
{
"NDCCode": "67850-023-10",
"PackageDescription": "10 VIAL in 1 PACKAGE (67850-023-10) / 250 mg in 1 VIAL (67850-023-00) ",
"NDC11Code": "67850-0023-10",
"ProductNDC": "67850-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin",
"NonProprietaryName": "Ampicillin Injection",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20190306",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090354",
"LabelerName": "Methapharm Inc.",
"SubstanceName": "AMPICILLIN SODIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/250mg",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190306",
"SamplePackage": "N",
"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 Infectionscaused by S treptococcus pneumoniae, Staphylococcus aureus(penicillinase and nonpenicillinase-producing), H. influenzae,and Group A beta-hemolytic Streptococci. Bacterial Meningitiscaused 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 Endocarditiscaused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds 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 streptococcal endocarditis. Urinary Tract Infectionscaused by sensitive strains of E. coliand P roteus mirabilis. Gastrointestinal Infectionscaused by Salmonella typhi(typhoid fever), other Salmonella spp., and Shigella spp. (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. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates. Each vial of Ampicillin for Injection, USP contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin. Ampicillin for Injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. It has the following molecular structure. The molecular formula is C 16H 18N 3NaO 4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10."
},
{
"NDCCode": "67850-024-10",
"PackageDescription": "10 VIAL in 1 PACKAGE (67850-024-10) / 500 mg in 1 VIAL (67850-024-00) ",
"NDC11Code": "67850-0024-10",
"ProductNDC": "67850-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin",
"NonProprietaryName": "Ampicillin Injection",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20190306",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090354",
"LabelerName": "Methapharm Inc.",
"SubstanceName": "AMPICILLIN SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/500mg",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190306",
"SamplePackage": "N",
"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 Infectionscaused by S treptococcus pneumoniae, Staphylococcus aureus(penicillinase and nonpenicillinase-producing), H. influenzae,and Group A beta-hemolytic Streptococci. Bacterial Meningitiscaused 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 Endocarditiscaused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds 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 streptococcal endocarditis. Urinary Tract Infectionscaused by sensitive strains of E. coliand P roteus mirabilis. Gastrointestinal Infectionscaused by Salmonella typhi(typhoid fever), other Salmonella spp., and Shigella spp. (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. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates. Each vial of Ampicillin for Injection, USP contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin. Ampicillin for Injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. It has the following molecular structure. The molecular formula is C 16H 18N 3NaO 4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10."
},
{
"NDCCode": "67850-031-10",
"PackageDescription": "10 VIAL in 1 CARTON (67850-031-10) / 1 g in 1 VIAL",
"NDC11Code": "67850-0031-10",
"ProductNDC": "67850-031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nafcillin",
"NonProprietaryName": "Nafcillin Injection",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20190305",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090560",
"LabelerName": "Methapharm Inc.",
"SubstanceName": "NAFCILLIN SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190305",
"SamplePackage": "N",
"IndicationAndUsage": "Nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see CLINICAL PHARMACOLOGY - Susceptibility Test Methods). Nafcillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to methicillin resistant Staphylococcus sp., therapy with Nafcillin for Injection should be discontinued and alternative therapy provided. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nafcillin for Injection and other antibacterial drugs. Nafcillin for Injection 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": "Nafcillin for Injection, USP is semisynthetic penicillin derived from the penicillin nucleus,6-amino-penicillanic acid. The chemical name of nafcillin sodium is Monosodium (2S, 5R, 6R)-6-(2-ethoxy-1-naphthamido)-3, 3-dimethyl-7-oxo-4-thia-1- azabicyclo [3.2.0]heptane-2-carboxylate monohydrate. It is resistant to inactivation by the enzyme penicillinase (beta-lactamase). The structural formula of nafcillin sodium is as follows. C 21H 21N 2NaO 5S ●H 2O MW=454.47. Nafcillin for Injection, USP for the intramuscular or intravenous route of administration, contains nafacilin sodium as a sterile white to off-white crystalline dry powder for reconstitution. The reconstituted solution is a clear and colorless solution. The pH of the reconstituted solution is 6 - 8.5. Nafcillin for Injection, USP contains nafcillin sodium as the monohydrate equivalent to 1 gram or 2 grams of nafcillin per vial and is buffered with approximately 38 mg sodium citrate per gram. The sodium content is about 66 mg [2.9 mEq] per gram."
},
{
"NDCCode": "67850-041-10",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (67850-041-10) / 10 mL in 1 VIAL, SINGLE-USE (67850-041-00) ",
"NDC11Code": "67850-0041-10",
"ProductNDC": "67850-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tranexamic Acid",
"NonProprietaryName": "Tranexamic Acid",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20181011",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202436",
"LabelerName": "Methapharm, Inc.",
"SubstanceName": "TRANEXAMIC ACID",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181011",
"SamplePackage": "N"
},
{
"NDCCode": "67850-042-10",
"PackageDescription": "10 AMPULE in 1 CARTON (67850-042-10) / 10 mL in 1 AMPULE (67850-042-00) ",
"NDC11Code": "67850-0042-10",
"ProductNDC": "67850-042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tranexamic Acid",
"NonProprietaryName": "Tranexamic Acid",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190311",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202436",
"LabelerName": "Methapharm, Inc.",
"SubstanceName": "TRANEXAMIC ACID",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190311",
"SamplePackage": "N",
"IndicationAndUsage": "Tranexamic Acid Injection is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.",
"Description": "Tranexamic acid is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid is a white crystalline powder. The structural formula is. Empirical Formula: C 8H 15NO 2Molecular Weight: 157.2. Each mL of the sterile solution for intravenous injection contains 100 mg tranexamic acid and Water for Injection to 1 mL. The aqueous solution for injection has a pH of 6.5 to 8.0."
},
{
"NDCCode": "67850-071-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (67850-071-10) / 2 mL in 1 VIAL, SINGLE-DOSE (67850-071-00) ",
"NDC11Code": "67850-0071-10",
"ProductNDC": "67850-071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215829",
"LabelerName": "Methapharm Inc.",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210203",
"SamplePackage": "N",
"IndicationAndUsage": "Verapamil Hydrochloride Injection, USP is indicated for the following: 1 Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong-Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration., 2 Temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (Wolff-Parkinson-White (W-P-W) and Lown-Ganong-Levine (L-G-L) syndromes).",
"Description": "Verapamil hydrochloride is a calcium antagonist or slow-channel inhibitor. Verapamil Hydrochloride Injection, USP is a sterile, nonpyrogenic solution containing verapamil hydrochloride 2.5 mg/mL and sodium chloride 8.5 mg/mL in water for injection. The solution contains no bacteriostat or antimicrobial agent and is intended for single-dose intravenous administration. May contain hydrochloric acid for pH adjustment; pH is 4.0 to 6.5. The chemical name of Verapamil Hydrochloride, USP is benzeneacetonitrile, α-[3-[{2-(3,4-dimethoxyphenyl)ethyl} methylamino] propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil hydrochloride is a white or practically white crystalline powder. It is practically odorless and has a bitter taste. It is soluble in water; freely soluble in chloroform; sparingly soluble in alcohol; practically insoluble in ether. It has the following structural formula. Molecular weight: 491.06. Molecular formula: C 27H 38N 2O 4∙ HCl. Verapamil hydrochloride is not chemically related to other antiarrhythmic drugs."
},
{
"NDCCode": "67850-072-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (67850-072-10) / 4 mL in 1 VIAL, SINGLE-DOSE (67850-072-00) ",
"NDC11Code": "67850-0072-10",
"ProductNDC": "67850-072",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215829",
"LabelerName": "Methapharm Inc.",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210203",
"SamplePackage": "N",
"IndicationAndUsage": "Verapamil Hydrochloride Injection, USP is indicated for the following: 1 Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong-Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration., 2 Temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (Wolff-Parkinson-White (W-P-W) and Lown-Ganong-Levine (L-G-L) syndromes).",
"Description": "Verapamil hydrochloride is a calcium antagonist or slow-channel inhibitor. Verapamil Hydrochloride Injection, USP is a sterile, nonpyrogenic solution containing verapamil hydrochloride 2.5 mg/mL and sodium chloride 8.5 mg/mL in water for injection. The solution contains no bacteriostat or antimicrobial agent and is intended for single-dose intravenous administration. May contain hydrochloric acid for pH adjustment; pH is 4.0 to 6.5. The chemical name of Verapamil Hydrochloride, USP is benzeneacetonitrile, α-[3-[{2-(3,4-dimethoxyphenyl)ethyl} methylamino] propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil hydrochloride is a white or practically white crystalline powder. It is practically odorless and has a bitter taste. It is soluble in water; freely soluble in chloroform; sparingly soluble in alcohol; practically insoluble in ether. It has the following structural formula. Molecular weight: 491.06. Molecular formula: C 27H 38N 2O 4∙ HCl. Verapamil hydrochloride is not chemically related to other antiarrhythmic drugs."
},
{
"NDCCode": "67850-130-10",
"PackageDescription": "10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00) ",
"NDC11Code": "67850-0130-10",
"ProductNDC": "67850-130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin And Sulbactam",
"NonProprietaryName": "Ampicillin And Sulbactam For Injection",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20220101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201406",
"LabelerName": "Methapharm, Inc.",
"SubstanceName": "AMPICILLIN SODIUM; SULBACTAM SODIUM",
"StrengthNumber": "1; .5",
"StrengthUnit": "g/1; g/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "N",
"IndicationAndUsage": "Ampicillin and Sulbactam for Injection, USP is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli,2 Klebsiella spp.2 (including K. pneumoniae2), Proteus mirabilis,2 Bacteroides fragilis,2 Enterobacter spp.,2 and Acinetobacter calcoaceticus.2. NOTE: For information on use in pediatric patients see PRECAUTIONS – Pediatric Use and CLINICAL STUDIES sections. Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae2), Bacteroides spp. (including B. fragilis), and Enterobacter spp.2. Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli,2 and Bacteroides spp.2 (including B. fragilis2). __________. 2Efficacy for this microorganism in this organ system was studied in fewer than 10 infections. While Ampicillin and Sulbactam for Injection, USP is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with Ampicillin and Sulbactam for Injection, USP due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to Ampicillin and Sulbactam for Injection, USP should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to Ampicillin and Sulbactam for Injection, USP. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies, when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of Ampicillin and Sulbactam for Injection, USP and other antibacterial drugs, Ampicillin and Sulbactam for Injection, USP should be used only to treat 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": "Ampicillin and Sulbactam for Injection, USP is an injectable antibacterial combination consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C16H18N3NaO4S. The structural formula is. Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C8H10NNaO5S with a molecular weight of 255.22. The structural formula is. Ampicillin and Sulbactam for Injection, USP, ampicillin sodium/sulbactam sodium parenteral combination, is available as a white to off-white dry powder for reconstitution. Ampicillin and Sulbactam for Injection, USP dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL. The pH of the solutions is between 8.0 and 10.0. Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL) are essentially colorless to pale yellow. The pH of dilute solutions remains the same. 1.5 g of Ampicillin and Sulbactam for Injection, USP (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt) parenteral contains approximately 115 mg (5 mEq) of sodium. 3 g of Ampicillin and Sulbactam for Injection, USP (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt) parenteral contains approximately 230 mg (10 mEq) of sodium."
},
{
"NDCCode": "67850-131-10",
"PackageDescription": "10 VIAL, GLASS in 1 CARTON (67850-131-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-131-00) ",
"NDC11Code": "67850-0131-10",
"ProductNDC": "67850-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin And Sulbactam",
"NonProprietaryName": "Ampicillin And Sulbactam For Injection",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20220101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201406",
"LabelerName": "Methapharm, Inc.",
"SubstanceName": "AMPICILLIN SODIUM; SULBACTAM SODIUM",
"StrengthNumber": "2; 1",
"StrengthUnit": "g/1; g/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "N",
"IndicationAndUsage": "Ampicillin and Sulbactam for Injection, USP is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli,2 Klebsiella spp.2 (including K. pneumoniae2), Proteus mirabilis,2 Bacteroides fragilis,2 Enterobacter spp.,2 and Acinetobacter calcoaceticus.2. NOTE: For information on use in pediatric patients see PRECAUTIONS – Pediatric Use and CLINICAL STUDIES sections. Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae2), Bacteroides spp. (including B. fragilis), and Enterobacter spp.2. Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli,2 and Bacteroides spp.2 (including B. fragilis2). __________. 2Efficacy for this microorganism in this organ system was studied in fewer than 10 infections. While Ampicillin and Sulbactam for Injection, USP is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with Ampicillin and Sulbactam for Injection, USP due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to Ampicillin and Sulbactam for Injection, USP should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to Ampicillin and Sulbactam for Injection, USP. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies, when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of Ampicillin and Sulbactam for Injection, USP and other antibacterial drugs, Ampicillin and Sulbactam for Injection, USP should be used only to treat 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": "Ampicillin and Sulbactam for Injection, USP is an injectable antibacterial combination consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C16H18N3NaO4S. The structural formula is. Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C8H10NNaO5S with a molecular weight of 255.22. The structural formula is. Ampicillin and Sulbactam for Injection, USP, ampicillin sodium/sulbactam sodium parenteral combination, is available as a white to off-white dry powder for reconstitution. Ampicillin and Sulbactam for Injection, USP dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL. The pH of the solutions is between 8.0 and 10.0. Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL) are essentially colorless to pale yellow. The pH of dilute solutions remains the same. 1.5 g of Ampicillin and Sulbactam for Injection, USP (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt) parenteral contains approximately 115 mg (5 mEq) of sodium. 3 g of Ampicillin and Sulbactam for Injection, USP (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt) parenteral contains approximately 230 mg (10 mEq) of sodium."
},
{
"NDCCode": "67850-150-10",
"PackageDescription": "10 VIAL, GLASS in 1 CARTON (67850-150-10) / 10 mL in 1 VIAL, GLASS (67850-150-00) ",
"NDC11Code": "67850-0150-10",
"ProductNDC": "67850-150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20211201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209524",
"LabelerName": "Methapharm, Inc.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20211201",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium for injection is a proton pump inhibitor (PPI) indicated in adults for the following: 1 Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of Erosive Esophagitis (EE). (1.1), 2 Pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome. (1.2).",
"Description": "The active ingredient in pantoprazole sodium for injection, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C 16H 14F 2N 3NaO 4S, with a molecular weight of 405.4. The structural formula is:. Pantoprazole sodium is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. The reconstituted solution of pantoprazole sodium for injection is in the pH range 9.0 to 10.5. Pantoprazole Sodium for Injection is supplied for intravenous administration as a sterile, freeze-dried powder in a single-dose clear glass vial fitted with a rubber stopper and crimp seal. Each vial contains 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium), edetate disodium (1 mg), and sodium hydroxide to adjust pH."
},
{
"NDCCode": "67850-150-25",
"PackageDescription": "25 VIAL, GLASS in 1 CARTON (67850-150-25) / 10 mL in 1 VIAL, GLASS (67850-150-00) ",
"NDC11Code": "67850-0150-25",
"ProductNDC": "67850-150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20211201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209524",
"LabelerName": "Methapharm, Inc.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20211201",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium for injection is a proton pump inhibitor (PPI) indicated in adults for the following: 1 Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of Erosive Esophagitis (EE). (1.1), 2 Pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome. (1.2).",
"Description": "The active ingredient in pantoprazole sodium for injection, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C 16H 14F 2N 3NaO 4S, with a molecular weight of 405.4. The structural formula is:. Pantoprazole sodium is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. The reconstituted solution of pantoprazole sodium for injection is in the pH range 9.0 to 10.5. Pantoprazole Sodium for Injection is supplied for intravenous administration as a sterile, freeze-dried powder in a single-dose clear glass vial fitted with a rubber stopper and crimp seal. Each vial contains 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium), edetate disodium (1 mg), and sodium hydroxide to adjust pH."
},
{
"NDCCode": "10695-032-10",
"PackageDescription": "1 kg in 1 BOTTLE (10695-032-10)",
"NDC11Code": "10695-0032-10",
"ProductNDC": "10695-032",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Thyroid",
"DosageFormName": "POWDER",
"StartMarketingDate": "20170301",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Willow Birch Pharma, Inc.",
"SubstanceName": "THYROID, UNSPECIFIED",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "11084-032-10",
"PackageDescription": "100 mL in 1 TUBE (11084-032-10) ",
"NDC11Code": "11084-0032-10",
"ProductNDC": "11084-032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stokoderm Sunscreen Pure",
"NonProprietaryName": "Avobenzone, Octocrylene, Octisalate, And Homosalate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "SC Johnson Professional USA, Inc.",
"SubstanceName": "AVOBENZONE; OCTOCRYLENE; OCTISALATE; HOMOSALATE",
"StrengthNumber": "3; 10; 3; 5",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210201",
"SamplePackage": "N",
"IndicationAndUsage": "SPF 30. helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "14783-032-02",
"PackageDescription": "1 CARTRIDGE in 1 BOX (14783-032-02) > 10 g in 1 CARTRIDGE (14783-032-01)",
"NDC11Code": "14783-0032-02",
"ProductNDC": "14783-032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel",
"ProprietaryNameSuffix": "Divine Polvos Compactos Doble Uso Fps 15 Edicion De Lujo Plateado/double Use Compact Spf 15 Silver Deluxe Edition Medium 6",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide, And Octinoxate",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130527",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE",
"StrengthNumber": ".062393; .049; .03",
"StrengthUnit": "g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "16714-032-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (16714-032-10)",
"NDC11Code": "16714-0032-10",
"ProductNDC": "16714-032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078254",
"LabelerName": "Northstar RxLLC",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-12-11"
},
{
"NDCCode": "17312-032-15",
"PackageDescription": "1 BOTTLE, DROPPER in 1 PACKAGE (17312-032-15) / 10 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "17312-0032-15",
"ProductNDC": "17312-032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Eyes Relief",
"NonProprietaryName": "Allium Cepa, Ambrosia, Apis, Euphrasia, Histamine Hydrochloricum, Sabadilla, Sulphur",
"DosageFormName": "LIQUID",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20170803",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "TRP Company",
"SubstanceName": "ALLIUM CEPA WHOLE; AMBROSIA ARTEMISIIFOLIA; APIS MELLIFERA; EUPHRASIA STRICTA; HISTAMINE; SCHOENOCAULON OFFICINALE SEED; SULFUR",
"StrengthNumber": "6; 6; 6; 6; 12; 6; 6",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170803",
"SamplePackage": "N",
"IndicationAndUsage": "Uses:* According to homeopathic indiciations these ingredients provide temporary relief from symptoms such as: Itchiness Excessive watering Redness Burning Swelling Acute, chronic, and seasonal eye allergies after serious causes have been ruled out by a physician. * These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "23359-032-10",
"PackageDescription": "10 mL in 1 BOTTLE (23359-032-10) ",
"NDC11Code": "23359-0032-10",
"ProductNDC": "23359-032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ninjacof",
"NonProprietaryName": "Chlophedianol Hcl And Pyrilamine Maleate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20141015",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Centurion Labs, LLC",
"SubstanceName": "CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE",
"StrengthNumber": "12.5; 12.5",
"StrengthUnit": "mg/5mL; mg/5mL",
"Status": "Active",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170918",
"SamplePackage": "N",
"IndicationAndUsage": "Uses Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: : 1 cough due to minor throat and bronchial irritation, 2 calms the cough control center and relieves coughing, 3 runny nose, 4 sneezing, 5 itching of the nose and throat, 6 itchy, watery eyes."
},
{
"NDCCode": "33342-032-10",
"PackageDescription": "90 TABLET in 1 BOTTLE (33342-032-10) ",
"NDC11Code": "33342-0032-10",
"ProductNDC": "33342-032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramipexole Dihydrochloride",
"NonProprietaryName": "Pramipexole Dihydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202164",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120921",
"SamplePackage": "N",
"IndicationAndUsage": "Pramipexole dihydrochloride tablets are a non-ergot dopamine agonist indicated for the treatment of. · Parkinson’s disease (PD) (1.1) Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).",
"Description": "Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10H17N3S2HClH2O, and its molecular weight is 302.26. Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets 0.125 mg: Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.118 mg pramipexole dihydrochloride.Pramipexole dihydrochloride tablets 0.25 mg: Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.235 mg pramipexole dihydrochloride.Pramipexole dihydrochloride tablets 0.5 mg: Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.47 mg pramipexole dihydrochloride.Pramipexole dihydrochloride 1 mg tablets: Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.94 mg pramipexole dihydrochloride.Pramipexole dihydrochloride 1.5 mg tablets: Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride.Inactive ingredients for all strengths of pramipexole dihydrochloride tablets consist of mannitol, pregelatinized starch, colloidal silicon dioxide, povidone, and magnesium stearate."
},
{
"NDCCode": "35208-032-10",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (35208-032-10) ",
"NDC11Code": "35208-0032-10",
"ProductNDC": "35208-032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20161003",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204511",
"LabelerName": "IntelliPharmaCeutics Corp.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"IndicationAndUsage": "Levetiracetam Extended-release Tablets USP is indicated as adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy.",
"Description": "Levetiracetam Extended-release Tablets USP is an antiepileptic drug available as 500 mg and 750 mg (white) extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam Extended-release Tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: hypromellose, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate and polyethylene glycol/ macrogol.The medication is combined with a drug release controlling polymer that provides a drug release at a controlled rate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. USP Dissolution Test Pending."
},
{
"NDCCode": "37000-402-01",
"PackageDescription": "1 KIT in 1 PACKAGE (37000-402-01) * 473 mL in 1 BOTTLE, PLASTIC (37000-032-04) * 8 CELLO PACK in 1 CARTON (37000-477-10) > 6 TABLET in 1 CELLO PACK",
"NDC11Code": "37000-0402-01",
"ProductNDC": "37000-402",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pepto-bismol",
"NonProprietaryName": "Bismuth Subsalicylate",
"DosageFormName": "KIT",
"StartMarketingDate": "20110912",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part335",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"Status": "Deprecated",
"LastUpdate": "2022-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20110912",
"SamplePackage": "N"
},
{
"NDCCode": "39328-032-50",
"PackageDescription": "5 TRAY in 1 CASE (39328-032-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 10.15 mL in 1 CUP, UNIT-DOSE (39328-032-10) ",
"NDC11Code": "39328-0032-50",
"ProductNDC": "39328-032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen Solution",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20230927",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Patrin Pharma, Inc.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "325",
"StrengthUnit": "mg/10.15mL",
"Status": "Active",
"LastUpdate": "2024-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230927",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves minor aches and pains due to: 1 headache, 2 muscular aches, 3 backache, 4 minor pain of arthritis, 5 the common cold, 6 toothache, 7 premenstrual and menstrual cramps."
},
{
"NDCCode": "39328-032-99",
"PackageDescription": "10 CUP, UNIT-DOSE in 1 CASE (39328-032-99) / 10.15 mL in 1 CUP, UNIT-DOSE (39328-032-10) / 10 in 1 TRAY",
"NDC11Code": "39328-0032-99",
"ProductNDC": "39328-032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen Solution",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20230927",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Patrin Pharma, Inc.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "325",
"StrengthUnit": "mg/10.15mL",
"Status": "Active",
"LastUpdate": "2024-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240513",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves minor aches and pains due to: 1 headache, 2 muscular aches, 3 backache, 4 minor pain of arthritis, 5 the common cold, 6 toothache, 7 premenstrual and menstrual cramps."
},
{
"NDCCode": "44647-032-10",
"PackageDescription": "10 VIAL in 1 CARTON (44647-032-10) / 20 mL in 1 VIAL (44647-032-01) ",
"NDC11Code": "44647-0032-10",
"ProductNDC": "44647-032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meropenem",
"NonProprietaryName": "Meropenem",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160419",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206086",
"LabelerName": "Savior Lifetec Corporation",
"SubstanceName": "MEROPENEM",
"StrengthNumber": "500",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Carbapenems [CS], Penem Antibacterial [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160419",
"SamplePackage": "N",
"IndicationAndUsage": "Meropenem for injection is a penem antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). ( 1.1) , 2 Complicated intra-abdominal infections (adult and pediatric patients). ( 1.2) , 3 Bacterial meningitis (pediatric patients 3 months of age and older only). ( 1.3) .",
"Description": "Meropenem for injection is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. It is (4R,5S,6S)-3- [[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxilic acid trihydrate. Its empirical formula is C 17H 25N 3O 5S∙3H 2O with a molecular weight of 437.52. Its structural formula is:. Meropenem for injection is a white to pale yellow crystalline powder. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. When re-constituted as instructed, each 1 gram meropenem for injection vial will deliver 1 gram of meropenem and 90.2 mg of sodium as sodium carbonate (3.92 mEq). Each 500 mg meropenem for injection vial will deliver 500 mg meropenem and 45.1 mg of sodium as sodium carbonate (1.96 mEq) [see Dosage and Administration (2.4)]."
},
{
"NDCCode": "49035-032-10",
"PackageDescription": "296 mL in 1 BOTTLE, GLASS (49035-032-10) ",
"NDC11Code": "49035-0032-10",
"ProductNDC": "49035-032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Magnesium Citrate",
"NonProprietaryName": "Magnesium Citrate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150630",
"EndMarketingDate": "20200630",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "EQUATE (Wal-Mart Stores, Inc.)",
"SubstanceName": "MAGNESIUM CITRATE",
"StrengthNumber": "1.745",
"StrengthUnit": "g/29.6mL",
"Status": "Deprecated",
"LastUpdate": "2020-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150630",
"EndMarketingDatePackage": "20200630",
"SamplePackage": "N"
},
{
"NDCCode": "49252-032-10",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (49252-032-10) ",
"NDC11Code": "49252-0032-10",
"ProductNDC": "49252-032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paliperidone",
"NonProprietaryName": "Paliperidone",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204452",
"LabelerName": "Inventia Healthcare Limited",
"SubstanceName": "PALIPERIDONE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190901",
"SamplePackage": "N",
"IndicationAndUsage": "Paliperidone is an atypical antipsychotic agent indicated for. Treatment of schizophrenia (1.1). Adults: Efficacy was established in three 6-week trials and one maintenance trial. (14.1). Adolescents (ages 12-17): Efficacy was established in one 6-week trial. (14.1). Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants (1.2). Efficacy was established in two 6-week trials in adult patients (14.2).",
"Description": "Paliperidone extended-release tablets contains paliperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone contains a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2 benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O3 and its molecular weight is 426.49. The structural formula is:. Paliperidone is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide. Paliperidone extended-release tablets are available in 1.5 mg (orange-brown), 3 mg (white), 6 mg (beige), and 9 mg (pink) strengths. Paliperidone extended-release tablets utilize coated matrix drug-release technology [see Description (11)]. Inactive ingredients are butylated hydroxytoluene, carbomer homopolymer, colloidal silicon dioxide, dibutyl sebacate, ethyl cellulose, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, polyethylene oxides, talc, titanium dioxide. The 1.5 mg and 6 mg tablets also contain ferric oxide yellow and ferric oxide red. The 9 mg tablets contain ferric oxide red. Paliperidone extended-release tablets uses coated matrix formulation to deliver paliperidone at a controlled rate. The delivery system which resembles the round shape tablet in appearance consists of active in a core surrounded by a semipermeable membrane. The matrix core is composed of the drug, release controlling polymers and excipients. The semipermiable membrane surrounding the core consists of polymers. Each tablet strength has a different colorant and printing markings. In an aqueous environment, such as the gastrointestinal tract, aqueous fluid enters the tablets core through semipermeable membrane that controls the rate at which aqueous medium enters the tablet core, which intern determine the lag of drug delivery. The hydrophilic polymers of the core hydrates, swells, creating a gel containing paliperidone which intern determine the rate of drug delivery."
},
{
"NDCCode": "49348-032-10",
"PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49348-032-10) ",
"NDC11Code": "49348-0032-10",
"ProductNDC": "49348-032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gentle Laxative",
"NonProprietaryName": "Bisacodyl",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20020325",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Strategic Sourcing Services, LLC (Sunmark)",
"SubstanceName": "BISACODYL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-11-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20020325",
"SamplePackage": "N"
},
{
"NDCCode": "49629-032-01",
"PackageDescription": "60 CARTON in 1 BOX (49629-032-01) > 3 BLISTER PACK in 1 CARTON > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "49629-0032-01",
"ProductNDC": "49629-032",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Telmisartan And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"StartMarketingDate": "20200501",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Rottendorf Pharma GmbH",
"SubstanceName": "HYDROCHLOROTHIAZIDE; TELMISARTAN",
"StrengthNumber": "12.5; 80",
"StrengthUnit": "mg/1; mg/1",
"Status": "Unfinished",
"LastUpdate": "2022-03-10",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "01-MAY-20"
}
]
}
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<NDCList>
<NDC>
<NDCCode>67850-032-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (67850-032-10) / 2 g in 1 VIAL</PackageDescription>
<NDC11Code>67850-0032-10</NDC11Code>
<ProductNDC>67850-032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nafcillin</ProprietaryName>
<NonProprietaryName>Nafcillin Injection</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20190305</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090560</ApplicationNumber>
<LabelerName>Methapharm Inc.</LabelerName>
<SubstanceName>NAFCILLIN SODIUM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/2g</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190305</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see CLINICAL PHARMACOLOGY - Susceptibility Test Methods). Nafcillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to methicillin resistant Staphylococcus sp., therapy with Nafcillin for Injection should be discontinued and alternative therapy provided. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nafcillin for Injection and other antibacterial drugs. Nafcillin for Injection 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>Nafcillin for Injection, USP is semisynthetic penicillin derived from the penicillin nucleus,6-amino-penicillanic acid. The chemical name of nafcillin sodium is Monosodium (2S, 5R, 6R)-6-(2-ethoxy-1-naphthamido)-3, 3-dimethyl-7-oxo-4-thia-1- azabicyclo [3.2.0]heptane-2-carboxylate monohydrate. It is resistant to inactivation by the enzyme penicillinase (beta-lactamase). The structural formula of nafcillin sodium is as follows. C 21H 21N 2NaO 5S ●H 2O MW=454.47. Nafcillin for Injection, USP for the intramuscular or intravenous route of administration, contains nafacilin sodium as a sterile white to off-white crystalline dry powder for reconstitution. The reconstituted solution is a clear and colorless solution. The pH of the reconstituted solution is 6 - 8.5. Nafcillin for Injection, USP contains nafcillin sodium as the monohydrate equivalent to 1 gram or 2 grams of nafcillin per vial and is buffered with approximately 38 mg sodium citrate per gram. The sodium content is about 66 mg [2.9 mEq] per gram.</Description>
</NDC>
<NDC>
<NDCCode>67850-021-10</NDCCode>
<PackageDescription>10 VIAL in 1 PACKAGE (67850-021-10) / 1 g in 1 VIAL (67850-021-00) </PackageDescription>
<NDC11Code>67850-0021-10</NDC11Code>
<ProductNDC>67850-021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin</ProprietaryName>
<NonProprietaryName>Ampicillin Injection</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20190306</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090354</ApplicationNumber>
<LabelerName>Methapharm Inc.</LabelerName>
<SubstanceName>AMPICILLIN SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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 Infectionscaused by S treptococcus pneumoniae, Staphylococcus aureus(penicillinase and nonpenicillinase-producing), H. influenzae,and Group A beta-hemolytic Streptococci. Bacterial Meningitiscaused 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 Endocarditiscaused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds 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 streptococcal endocarditis. Urinary Tract Infectionscaused by sensitive strains of E. coliand P roteus mirabilis. Gastrointestinal Infectionscaused by Salmonella typhi(typhoid fever), other Salmonella spp., and Shigella spp. (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. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates. Each vial of Ampicillin for Injection, USP contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin. Ampicillin for Injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. It has the following molecular structure. The molecular formula is C 16H 18N 3NaO 4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10.</Description>
</NDC>
<NDC>
<NDCCode>67850-022-10</NDCCode>
<PackageDescription>10 VIAL in 1 PACKAGE (67850-022-10) / 2 g in 1 VIAL (67850-022-00) </PackageDescription>
<NDC11Code>67850-0022-10</NDC11Code>
<ProductNDC>67850-022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin</ProprietaryName>
<NonProprietaryName>Ampicillin Injection</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20190306</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090354</ApplicationNumber>
<LabelerName>Methapharm Inc.</LabelerName>
<SubstanceName>AMPICILLIN SODIUM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/2g</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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 Infectionscaused by S treptococcus pneumoniae, Staphylococcus aureus(penicillinase and nonpenicillinase-producing), H. influenzae,and Group A beta-hemolytic Streptococci. Bacterial Meningitiscaused 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 Endocarditiscaused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds 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 streptococcal endocarditis. Urinary Tract Infectionscaused by sensitive strains of E. coliand P roteus mirabilis. Gastrointestinal Infectionscaused by Salmonella typhi(typhoid fever), other Salmonella spp., and Shigella spp. (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. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates. Each vial of Ampicillin for Injection, USP contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin. Ampicillin for Injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. It has the following molecular structure. The molecular formula is C 16H 18N 3NaO 4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10.</Description>
</NDC>
<NDC>
<NDCCode>67850-023-10</NDCCode>
<PackageDescription>10 VIAL in 1 PACKAGE (67850-023-10) / 250 mg in 1 VIAL (67850-023-00) </PackageDescription>
<NDC11Code>67850-0023-10</NDC11Code>
<ProductNDC>67850-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin</ProprietaryName>
<NonProprietaryName>Ampicillin Injection</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20190306</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090354</ApplicationNumber>
<LabelerName>Methapharm Inc.</LabelerName>
<SubstanceName>AMPICILLIN SODIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/250mg</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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 Infectionscaused by S treptococcus pneumoniae, Staphylococcus aureus(penicillinase and nonpenicillinase-producing), H. influenzae,and Group A beta-hemolytic Streptococci. Bacterial Meningitiscaused 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 Endocarditiscaused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds 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 streptococcal endocarditis. Urinary Tract Infectionscaused by sensitive strains of E. coliand P roteus mirabilis. Gastrointestinal Infectionscaused by Salmonella typhi(typhoid fever), other Salmonella spp., and Shigella spp. (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. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates. Each vial of Ampicillin for Injection, USP contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin. Ampicillin for Injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. It has the following molecular structure. The molecular formula is C 16H 18N 3NaO 4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10.</Description>
</NDC>
<NDC>
<NDCCode>67850-024-10</NDCCode>
<PackageDescription>10 VIAL in 1 PACKAGE (67850-024-10) / 500 mg in 1 VIAL (67850-024-00) </PackageDescription>
<NDC11Code>67850-0024-10</NDC11Code>
<ProductNDC>67850-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin</ProprietaryName>
<NonProprietaryName>Ampicillin Injection</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20190306</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090354</ApplicationNumber>
<LabelerName>Methapharm Inc.</LabelerName>
<SubstanceName>AMPICILLIN SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/500mg</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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 Infectionscaused by S treptococcus pneumoniae, Staphylococcus aureus(penicillinase and nonpenicillinase-producing), H. influenzae,and Group A beta-hemolytic Streptococci. Bacterial Meningitiscaused 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 Endocarditiscaused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds 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 streptococcal endocarditis. Urinary Tract Infectionscaused by sensitive strains of E. coliand P roteus mirabilis. Gastrointestinal Infectionscaused by Salmonella typhi(typhoid fever), other Salmonella spp., and Shigella spp. (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. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates. Each vial of Ampicillin for Injection, USP contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin. Ampicillin for Injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. It has the following molecular structure. The molecular formula is C 16H 18N 3NaO 4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10.</Description>
</NDC>
<NDC>
<NDCCode>67850-031-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (67850-031-10) / 1 g in 1 VIAL</PackageDescription>
<NDC11Code>67850-0031-10</NDC11Code>
<ProductNDC>67850-031</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nafcillin</ProprietaryName>
<NonProprietaryName>Nafcillin Injection</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20190305</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090560</ApplicationNumber>
<LabelerName>Methapharm Inc.</LabelerName>
<SubstanceName>NAFCILLIN SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190305</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see CLINICAL PHARMACOLOGY - Susceptibility Test Methods). Nafcillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to methicillin resistant Staphylococcus sp., therapy with Nafcillin for Injection should be discontinued and alternative therapy provided. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nafcillin for Injection and other antibacterial drugs. Nafcillin for Injection 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>Nafcillin for Injection, USP is semisynthetic penicillin derived from the penicillin nucleus,6-amino-penicillanic acid. The chemical name of nafcillin sodium is Monosodium (2S, 5R, 6R)-6-(2-ethoxy-1-naphthamido)-3, 3-dimethyl-7-oxo-4-thia-1- azabicyclo [3.2.0]heptane-2-carboxylate monohydrate. It is resistant to inactivation by the enzyme penicillinase (beta-lactamase). The structural formula of nafcillin sodium is as follows. C 21H 21N 2NaO 5S ●H 2O MW=454.47. Nafcillin for Injection, USP for the intramuscular or intravenous route of administration, contains nafacilin sodium as a sterile white to off-white crystalline dry powder for reconstitution. The reconstituted solution is a clear and colorless solution. The pH of the reconstituted solution is 6 - 8.5. Nafcillin for Injection, USP contains nafcillin sodium as the monohydrate equivalent to 1 gram or 2 grams of nafcillin per vial and is buffered with approximately 38 mg sodium citrate per gram. The sodium content is about 66 mg [2.9 mEq] per gram.</Description>
</NDC>
<NDC>
<NDCCode>67850-041-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (67850-041-10) / 10 mL in 1 VIAL, SINGLE-USE (67850-041-00) </PackageDescription>
<NDC11Code>67850-0041-10</NDC11Code>
<ProductNDC>67850-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tranexamic Acid</ProprietaryName>
<NonProprietaryName>Tranexamic Acid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20181011</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202436</ApplicationNumber>
<LabelerName>Methapharm, Inc.</LabelerName>
<SubstanceName>TRANEXAMIC ACID</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67850-042-10</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (67850-042-10) / 10 mL in 1 AMPULE (67850-042-00) </PackageDescription>
<NDC11Code>67850-0042-10</NDC11Code>
<ProductNDC>67850-042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tranexamic Acid</ProprietaryName>
<NonProprietaryName>Tranexamic Acid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190311</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202436</ApplicationNumber>
<LabelerName>Methapharm, Inc.</LabelerName>
<SubstanceName>TRANEXAMIC ACID</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190311</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tranexamic Acid Injection is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.</IndicationAndUsage>
<Description>Tranexamic acid is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid is a white crystalline powder. The structural formula is. Empirical Formula: C 8H 15NO 2Molecular Weight: 157.2. Each mL of the sterile solution for intravenous injection contains 100 mg tranexamic acid and Water for Injection to 1 mL. The aqueous solution for injection has a pH of 6.5 to 8.0.</Description>
</NDC>
<NDC>
<NDCCode>67850-071-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (67850-071-10) / 2 mL in 1 VIAL, SINGLE-DOSE (67850-071-00) </PackageDescription>
<NDC11Code>67850-0071-10</NDC11Code>
<ProductNDC>67850-071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215829</ApplicationNumber>
<LabelerName>Methapharm Inc.</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Verapamil Hydrochloride Injection, USP is indicated for the following: 1 Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong-Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration., 2 Temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (Wolff-Parkinson-White (W-P-W) and Lown-Ganong-Levine (L-G-L) syndromes).</IndicationAndUsage>
<Description>Verapamil hydrochloride is a calcium antagonist or slow-channel inhibitor. Verapamil Hydrochloride Injection, USP is a sterile, nonpyrogenic solution containing verapamil hydrochloride 2.5 mg/mL and sodium chloride 8.5 mg/mL in water for injection. The solution contains no bacteriostat or antimicrobial agent and is intended for single-dose intravenous administration. May contain hydrochloric acid for pH adjustment; pH is 4.0 to 6.5. The chemical name of Verapamil Hydrochloride, USP is benzeneacetonitrile, α-[3-[{2-(3,4-dimethoxyphenyl)ethyl} methylamino] propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil hydrochloride is a white or practically white crystalline powder. It is practically odorless and has a bitter taste. It is soluble in water; freely soluble in chloroform; sparingly soluble in alcohol; practically insoluble in ether. It has the following structural formula. Molecular weight: 491.06. Molecular formula: C 27H 38N 2O 4∙ HCl. Verapamil hydrochloride is not chemically related to other antiarrhythmic drugs.</Description>
</NDC>
<NDC>
<NDCCode>67850-072-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (67850-072-10) / 4 mL in 1 VIAL, SINGLE-DOSE (67850-072-00) </PackageDescription>
<NDC11Code>67850-0072-10</NDC11Code>
<ProductNDC>67850-072</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215829</ApplicationNumber>
<LabelerName>Methapharm Inc.</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Verapamil Hydrochloride Injection, USP is indicated for the following: 1 Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong-Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration., 2 Temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (Wolff-Parkinson-White (W-P-W) and Lown-Ganong-Levine (L-G-L) syndromes).</IndicationAndUsage>
<Description>Verapamil hydrochloride is a calcium antagonist or slow-channel inhibitor. Verapamil Hydrochloride Injection, USP is a sterile, nonpyrogenic solution containing verapamil hydrochloride 2.5 mg/mL and sodium chloride 8.5 mg/mL in water for injection. The solution contains no bacteriostat or antimicrobial agent and is intended for single-dose intravenous administration. May contain hydrochloric acid for pH adjustment; pH is 4.0 to 6.5. The chemical name of Verapamil Hydrochloride, USP is benzeneacetonitrile, α-[3-[{2-(3,4-dimethoxyphenyl)ethyl} methylamino] propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil hydrochloride is a white or practically white crystalline powder. It is practically odorless and has a bitter taste. It is soluble in water; freely soluble in chloroform; sparingly soluble in alcohol; practically insoluble in ether. It has the following structural formula. Molecular weight: 491.06. Molecular formula: C 27H 38N 2O 4∙ HCl. Verapamil hydrochloride is not chemically related to other antiarrhythmic drugs.</Description>
</NDC>
<NDC>
<NDCCode>67850-130-10</NDCCode>
<PackageDescription>10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00) </PackageDescription>
<NDC11Code>67850-0130-10</NDC11Code>
<ProductNDC>67850-130</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin And Sulbactam</ProprietaryName>
<NonProprietaryName>Ampicillin And Sulbactam For Injection</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20220101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201406</ApplicationNumber>
<LabelerName>Methapharm, Inc.</LabelerName>
<SubstanceName>AMPICILLIN SODIUM; SULBACTAM SODIUM</SubstanceName>
<StrengthNumber>1; .5</StrengthNumber>
<StrengthUnit>g/1; g/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ampicillin and Sulbactam for Injection, USP is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli,2 Klebsiella spp.2 (including K. pneumoniae2), Proteus mirabilis,2 Bacteroides fragilis,2 Enterobacter spp.,2 and Acinetobacter calcoaceticus.2. NOTE: For information on use in pediatric patients see PRECAUTIONS – Pediatric Use and CLINICAL STUDIES sections. Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae2), Bacteroides spp. (including B. fragilis), and Enterobacter spp.2. Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli,2 and Bacteroides spp.2 (including B. fragilis2). __________. 2Efficacy for this microorganism in this organ system was studied in fewer than 10 infections. While Ampicillin and Sulbactam for Injection, USP is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with Ampicillin and Sulbactam for Injection, USP due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to Ampicillin and Sulbactam for Injection, USP should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to Ampicillin and Sulbactam for Injection, USP. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies, when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of Ampicillin and Sulbactam for Injection, USP and other antibacterial drugs, Ampicillin and Sulbactam for Injection, USP should be used only to treat 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>Ampicillin and Sulbactam for Injection, USP is an injectable antibacterial combination consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C16H18N3NaO4S. The structural formula is. Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C8H10NNaO5S with a molecular weight of 255.22. The structural formula is. Ampicillin and Sulbactam for Injection, USP, ampicillin sodium/sulbactam sodium parenteral combination, is available as a white to off-white dry powder for reconstitution. Ampicillin and Sulbactam for Injection, USP dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL. The pH of the solutions is between 8.0 and 10.0. Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL) are essentially colorless to pale yellow. The pH of dilute solutions remains the same. 1.5 g of Ampicillin and Sulbactam for Injection, USP (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt) parenteral contains approximately 115 mg (5 mEq) of sodium. 3 g of Ampicillin and Sulbactam for Injection, USP (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt) parenteral contains approximately 230 mg (10 mEq) of sodium.</Description>
</NDC>
<NDC>
<NDCCode>67850-131-10</NDCCode>
<PackageDescription>10 VIAL, GLASS in 1 CARTON (67850-131-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-131-00) </PackageDescription>
<NDC11Code>67850-0131-10</NDC11Code>
<ProductNDC>67850-131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin And Sulbactam</ProprietaryName>
<NonProprietaryName>Ampicillin And Sulbactam For Injection</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20220101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201406</ApplicationNumber>
<LabelerName>Methapharm, Inc.</LabelerName>
<SubstanceName>AMPICILLIN SODIUM; SULBACTAM SODIUM</SubstanceName>
<StrengthNumber>2; 1</StrengthNumber>
<StrengthUnit>g/1; g/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ampicillin and Sulbactam for Injection, USP is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli,2 Klebsiella spp.2 (including K. pneumoniae2), Proteus mirabilis,2 Bacteroides fragilis,2 Enterobacter spp.,2 and Acinetobacter calcoaceticus.2. NOTE: For information on use in pediatric patients see PRECAUTIONS – Pediatric Use and CLINICAL STUDIES sections. Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae2), Bacteroides spp. (including B. fragilis), and Enterobacter spp.2. Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli,2 and Bacteroides spp.2 (including B. fragilis2). __________. 2Efficacy for this microorganism in this organ system was studied in fewer than 10 infections. While Ampicillin and Sulbactam for Injection, USP is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with Ampicillin and Sulbactam for Injection, USP due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to Ampicillin and Sulbactam for Injection, USP should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to Ampicillin and Sulbactam for Injection, USP. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies, when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of Ampicillin and Sulbactam for Injection, USP and other antibacterial drugs, Ampicillin and Sulbactam for Injection, USP should be used only to treat 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>Ampicillin and Sulbactam for Injection, USP is an injectable antibacterial combination consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C16H18N3NaO4S. The structural formula is. Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C8H10NNaO5S with a molecular weight of 255.22. The structural formula is. Ampicillin and Sulbactam for Injection, USP, ampicillin sodium/sulbactam sodium parenteral combination, is available as a white to off-white dry powder for reconstitution. Ampicillin and Sulbactam for Injection, USP dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL. The pH of the solutions is between 8.0 and 10.0. Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL) are essentially colorless to pale yellow. The pH of dilute solutions remains the same. 1.5 g of Ampicillin and Sulbactam for Injection, USP (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt) parenteral contains approximately 115 mg (5 mEq) of sodium. 3 g of Ampicillin and Sulbactam for Injection, USP (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt) parenteral contains approximately 230 mg (10 mEq) of sodium.</Description>
</NDC>
<NDC>
<NDCCode>67850-150-10</NDCCode>
<PackageDescription>10 VIAL, GLASS in 1 CARTON (67850-150-10) / 10 mL in 1 VIAL, GLASS (67850-150-00) </PackageDescription>
<NDC11Code>67850-0150-10</NDC11Code>
<ProductNDC>67850-150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20211201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209524</ApplicationNumber>
<LabelerName>Methapharm, Inc.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium for injection is a proton pump inhibitor (PPI) indicated in adults for the following: 1 Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of Erosive Esophagitis (EE). (1.1), 2 Pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome. (1.2).</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium for injection, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C 16H 14F 2N 3NaO 4S, with a molecular weight of 405.4. The structural formula is:. Pantoprazole sodium is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. The reconstituted solution of pantoprazole sodium for injection is in the pH range 9.0 to 10.5. Pantoprazole Sodium for Injection is supplied for intravenous administration as a sterile, freeze-dried powder in a single-dose clear glass vial fitted with a rubber stopper and crimp seal. Each vial contains 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium), edetate disodium (1 mg), and sodium hydroxide to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>67850-150-25</NDCCode>
<PackageDescription>25 VIAL, GLASS in 1 CARTON (67850-150-25) / 10 mL in 1 VIAL, GLASS (67850-150-00) </PackageDescription>
<NDC11Code>67850-0150-25</NDC11Code>
<ProductNDC>67850-150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20211201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209524</ApplicationNumber>
<LabelerName>Methapharm, Inc.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium for injection is a proton pump inhibitor (PPI) indicated in adults for the following: 1 Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of Erosive Esophagitis (EE). (1.1), 2 Pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome. (1.2).</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium for injection, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C 16H 14F 2N 3NaO 4S, with a molecular weight of 405.4. The structural formula is:. Pantoprazole sodium is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. The reconstituted solution of pantoprazole sodium for injection is in the pH range 9.0 to 10.5. Pantoprazole Sodium for Injection is supplied for intravenous administration as a sterile, freeze-dried powder in a single-dose clear glass vial fitted with a rubber stopper and crimp seal. Each vial contains 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium), edetate disodium (1 mg), and sodium hydroxide to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>10695-032-10</NDCCode>
<PackageDescription>1 kg in 1 BOTTLE (10695-032-10)</PackageDescription>
<NDC11Code>10695-0032-10</NDC11Code>
<ProductNDC>10695-032</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Thyroid</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20170301</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Willow Birch Pharma, Inc.</LabelerName>
<SubstanceName>THYROID, UNSPECIFIED</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11084-032-10</NDCCode>
<PackageDescription>100 mL in 1 TUBE (11084-032-10) </PackageDescription>
<NDC11Code>11084-0032-10</NDC11Code>
<ProductNDC>11084-032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stokoderm Sunscreen Pure</ProprietaryName>
<NonProprietaryName>Avobenzone, Octocrylene, Octisalate, And Homosalate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>SC Johnson Professional USA, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; OCTOCRYLENE; OCTISALATE; HOMOSALATE</SubstanceName>
<StrengthNumber>3; 10; 3; 5</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SPF 30. helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14783-032-02</NDCCode>
<PackageDescription>1 CARTRIDGE in 1 BOX (14783-032-02) > 10 g in 1 CARTRIDGE (14783-032-01)</PackageDescription>
<NDC11Code>14783-0032-02</NDC11Code>
<ProductNDC>14783-032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel</ProprietaryName>
<ProprietaryNameSuffix>Divine Polvos Compactos Doble Uso Fps 15 Edicion De Lujo Plateado/double Use Compact Spf 15 Silver Deluxe Edition Medium 6</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide, And Octinoxate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130527</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE</SubstanceName>
<StrengthNumber>.062393; .049; .03</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16714-032-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (16714-032-10)</PackageDescription>
<NDC11Code>16714-0032-10</NDC11Code>
<ProductNDC>16714-032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol</ProprietaryName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078254</ApplicationNumber>
<LabelerName>Northstar RxLLC</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-12-11</LastUpdate>
</NDC>
<NDC>
<NDCCode>17312-032-15</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 PACKAGE (17312-032-15) / 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>17312-0032-15</NDC11Code>
<ProductNDC>17312-032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Eyes Relief</ProprietaryName>
<NonProprietaryName>Allium Cepa, Ambrosia, Apis, Euphrasia, Histamine Hydrochloricum, Sabadilla, Sulphur</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20170803</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>TRP Company</LabelerName>
<SubstanceName>ALLIUM CEPA WHOLE; AMBROSIA ARTEMISIIFOLIA; APIS MELLIFERA; EUPHRASIA STRICTA; HISTAMINE; SCHOENOCAULON OFFICINALE SEED; SULFUR</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 12; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses:* According to homeopathic indiciations these ingredients provide temporary relief from symptoms such as: Itchiness Excessive watering Redness Burning Swelling Acute, chronic, and seasonal eye allergies after serious causes have been ruled out by a physician. * These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>23359-032-10</NDCCode>
<PackageDescription>10 mL in 1 BOTTLE (23359-032-10) </PackageDescription>
<NDC11Code>23359-0032-10</NDC11Code>
<ProductNDC>23359-032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ninjacof</ProprietaryName>
<NonProprietaryName>Chlophedianol Hcl And Pyrilamine Maleate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141015</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Centurion Labs, LLC</LabelerName>
<SubstanceName>CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE</SubstanceName>
<StrengthNumber>12.5; 12.5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: : 1 cough due to minor throat and bronchial irritation, 2 calms the cough control center and relieves coughing, 3 runny nose, 4 sneezing, 5 itching of the nose and throat, 6 itchy, watery eyes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>33342-032-10</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (33342-032-10) </PackageDescription>
<NDC11Code>33342-0032-10</NDC11Code>
<ProductNDC>33342-032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
<NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202164</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pramipexole dihydrochloride tablets are a non-ergot dopamine agonist indicated for the treatment of. · Parkinson’s disease (PD) (1.1) Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).</IndicationAndUsage>
<Description>Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10H17N3S2HClH2O, and its molecular weight is 302.26. Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets 0.125 mg: Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.118 mg pramipexole dihydrochloride.Pramipexole dihydrochloride tablets 0.25 mg: Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.235 mg pramipexole dihydrochloride.Pramipexole dihydrochloride tablets 0.5 mg: Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.47 mg pramipexole dihydrochloride.Pramipexole dihydrochloride 1 mg tablets: Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.94 mg pramipexole dihydrochloride.Pramipexole dihydrochloride 1.5 mg tablets: Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride.Inactive ingredients for all strengths of pramipexole dihydrochloride tablets consist of mannitol, pregelatinized starch, colloidal silicon dioxide, povidone, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>35208-032-10</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (35208-032-10) </PackageDescription>
<NDC11Code>35208-0032-10</NDC11Code>
<ProductNDC>35208-032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161003</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204511</ApplicationNumber>
<LabelerName>IntelliPharmaCeutics Corp.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Levetiracetam Extended-release Tablets USP is indicated as adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy.</IndicationAndUsage>
<Description>Levetiracetam Extended-release Tablets USP is an antiepileptic drug available as 500 mg and 750 mg (white) extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam Extended-release Tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: hypromellose, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate and polyethylene glycol/ macrogol.The medication is combined with a drug release controlling polymer that provides a drug release at a controlled rate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. USP Dissolution Test Pending.</Description>
</NDC>
<NDC>
<NDCCode>37000-402-01</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (37000-402-01) * 473 mL in 1 BOTTLE, PLASTIC (37000-032-04) * 8 CELLO PACK in 1 CARTON (37000-477-10) > 6 TABLET in 1 CELLO PACK</PackageDescription>
<NDC11Code>37000-0402-01</NDC11Code>
<ProductNDC>37000-402</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pepto-bismol</ProprietaryName>
<NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20110912</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part335</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2022-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>39328-032-50</NDCCode>
<PackageDescription>5 TRAY in 1 CASE (39328-032-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 10.15 mL in 1 CUP, UNIT-DOSE (39328-032-10) </PackageDescription>
<NDC11Code>39328-0032-50</NDC11Code>
<ProductNDC>39328-032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen Solution</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230927</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Patrin Pharma, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/10.15mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves minor aches and pains due to: 1 headache, 2 muscular aches, 3 backache, 4 minor pain of arthritis, 5 the common cold, 6 toothache, 7 premenstrual and menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>39328-032-99</NDCCode>
<PackageDescription>10 CUP, UNIT-DOSE in 1 CASE (39328-032-99) / 10.15 mL in 1 CUP, UNIT-DOSE (39328-032-10) / 10 in 1 TRAY</PackageDescription>
<NDC11Code>39328-0032-99</NDC11Code>
<ProductNDC>39328-032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen Solution</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230927</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Patrin Pharma, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/10.15mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves minor aches and pains due to: 1 headache, 2 muscular aches, 3 backache, 4 minor pain of arthritis, 5 the common cold, 6 toothache, 7 premenstrual and menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>44647-032-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (44647-032-10) / 20 mL in 1 VIAL (44647-032-01) </PackageDescription>
<NDC11Code>44647-0032-10</NDC11Code>
<ProductNDC>44647-032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meropenem</ProprietaryName>
<NonProprietaryName>Meropenem</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160419</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206086</ApplicationNumber>
<LabelerName>Savior Lifetec Corporation</LabelerName>
<SubstanceName>MEROPENEM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Carbapenems [CS], Penem Antibacterial [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meropenem for injection is a penem antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). ( 1.1) , 2 Complicated intra-abdominal infections (adult and pediatric patients). ( 1.2) , 3 Bacterial meningitis (pediatric patients 3 months of age and older only). ( 1.3) .</IndicationAndUsage>
<Description>Meropenem for injection is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. It is (4R,5S,6S)-3- [[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxilic acid trihydrate. Its empirical formula is C 17H 25N 3O 5S∙3H 2O with a molecular weight of 437.52. Its structural formula is:. Meropenem for injection is a white to pale yellow crystalline powder. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. When re-constituted as instructed, each 1 gram meropenem for injection vial will deliver 1 gram of meropenem and 90.2 mg of sodium as sodium carbonate (3.92 mEq). Each 500 mg meropenem for injection vial will deliver 500 mg meropenem and 45.1 mg of sodium as sodium carbonate (1.96 mEq) [see Dosage and Administration (2.4)].</Description>
</NDC>
<NDC>
<NDCCode>49035-032-10</NDCCode>
<PackageDescription>296 mL in 1 BOTTLE, GLASS (49035-032-10) </PackageDescription>
<NDC11Code>49035-0032-10</NDC11Code>
<ProductNDC>49035-032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Magnesium Citrate</ProprietaryName>
<NonProprietaryName>Magnesium Citrate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150630</StartMarketingDate>
<EndMarketingDate>20200630</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>EQUATE (Wal-Mart Stores, Inc.)</LabelerName>
<SubstanceName>MAGNESIUM CITRATE</SubstanceName>
<StrengthNumber>1.745</StrengthNumber>
<StrengthUnit>g/29.6mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150630</StartMarketingDatePackage>
<EndMarketingDatePackage>20200630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49252-032-10</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (49252-032-10) </PackageDescription>
<NDC11Code>49252-0032-10</NDC11Code>
<ProductNDC>49252-032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paliperidone</ProprietaryName>
<NonProprietaryName>Paliperidone</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204452</ApplicationNumber>
<LabelerName>Inventia Healthcare Limited</LabelerName>
<SubstanceName>PALIPERIDONE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paliperidone is an atypical antipsychotic agent indicated for. Treatment of schizophrenia (1.1). Adults: Efficacy was established in three 6-week trials and one maintenance trial. (14.1). Adolescents (ages 12-17): Efficacy was established in one 6-week trial. (14.1). Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants (1.2). Efficacy was established in two 6-week trials in adult patients (14.2).</IndicationAndUsage>
<Description>Paliperidone extended-release tablets contains paliperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone contains a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2 benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O3 and its molecular weight is 426.49. The structural formula is:. Paliperidone is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide. Paliperidone extended-release tablets are available in 1.5 mg (orange-brown), 3 mg (white), 6 mg (beige), and 9 mg (pink) strengths. Paliperidone extended-release tablets utilize coated matrix drug-release technology [see Description (11)]. Inactive ingredients are butylated hydroxytoluene, carbomer homopolymer, colloidal silicon dioxide, dibutyl sebacate, ethyl cellulose, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, polyethylene oxides, talc, titanium dioxide. The 1.5 mg and 6 mg tablets also contain ferric oxide yellow and ferric oxide red. The 9 mg tablets contain ferric oxide red. Paliperidone extended-release tablets uses coated matrix formulation to deliver paliperidone at a controlled rate. The delivery system which resembles the round shape tablet in appearance consists of active in a core surrounded by a semipermeable membrane. The matrix core is composed of the drug, release controlling polymers and excipients. The semipermiable membrane surrounding the core consists of polymers. Each tablet strength has a different colorant and printing markings. In an aqueous environment, such as the gastrointestinal tract, aqueous fluid enters the tablets core through semipermeable membrane that controls the rate at which aqueous medium enters the tablet core, which intern determine the lag of drug delivery. The hydrophilic polymers of the core hydrates, swells, creating a gel containing paliperidone which intern determine the rate of drug delivery.</Description>
</NDC>
<NDC>
<NDCCode>49348-032-10</NDCCode>
<PackageDescription>100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49348-032-10) </PackageDescription>
<NDC11Code>49348-0032-10</NDC11Code>
<ProductNDC>49348-032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gentle Laxative</ProprietaryName>
<NonProprietaryName>Bisacodyl</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020325</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Strategic Sourcing Services, LLC (Sunmark)</LabelerName>
<SubstanceName>BISACODYL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020325</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49629-032-01</NDCCode>
<PackageDescription>60 CARTON in 1 BOX (49629-032-01) > 3 BLISTER PACK in 1 CARTON > 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>49629-0032-01</NDC11Code>
<ProductNDC>49629-032</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Telmisartan And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20200501</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Rottendorf Pharma GmbH</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE; TELMISARTAN</SubstanceName>
<StrengthNumber>12.5; 80</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-03-10</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-MAY-20</StartMarketingDatePackage>
</NDC>
</NDCList>