{
"NDC": [
{
"NDCCode": "83634-104-20",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (83634-104-20) / 10 mL in 1 VIAL, SINGLE-DOSE (83634-104-41) ",
"NDC11Code": "83634-0104-20",
"ProductNDC": "83634-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Piperacillin And Tazobactam",
"NonProprietaryName": "Piperacillin And Tazobactam",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065523",
"LabelerName": "Avenacy, LLC",
"SubstanceName": "PIPERACILLIN SODIUM; TAZOBACTAM SODIUM",
"StrengthNumber": "2; .25",
"StrengthUnit": "g/10mL; g/10mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250201",
"SamplePackage": "N",
"IndicationAndUsage": "Piperacillin and tazobactam for injection is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: : 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1) , 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2) , 3 Skin and skin structure infections in adults (1.3) , 4 Female pelvic infections in adults (1.4) , 5 Community-acquired pneumonia in adults (1.5) .",
"Description": "Piperacillin and Tazobactam for Injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is:. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is:. Piperacillin and Tazobactam for Injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Piperacillin and Tazobactam for Injection, USP, is a white to off-white sterile, lyophilized powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. This product does not contain excipients or preservatives. Each Piperacillin and Tazobactam for Injection, USP 2.25 gram single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 grams of tazobactam. Each vial contains 4.69 mEq (108 mg) of sodium. Each Piperacillin and Tazobactam for Injection, USP 3.375 gram single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 grams of tazobactam. Each vial contains 7.04 mEq (162 mg) of sodium. Each Piperacillin and Tazobactam for Injection, USP 4.5 gram single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 grams of tazobactam. Each vial contains 9.39 mEq (216 mg) of sodium. Meets USP Organic Impurities Test 3."
},
{
"NDCCode": "83634-102-20",
"PackageDescription": "10 VIAL in 1 CARTON (83634-102-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (83634-102-41) ",
"NDC11Code": "83634-0102-20",
"ProductNDC": "83634-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillin G Potassium",
"NonProprietaryName": "Penicillin G Potassium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20250201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065448",
"LabelerName": "Avenacy Inc.",
"SubstanceName": "PENICILLIN G POTASSIUM",
"StrengthNumber": "5000000",
"StrengthUnit": "[iU]/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250201",
"SamplePackage": "N",
"IndicationAndUsage": "Penicillin G Potassium for Injection is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Appropriate culture and susceptibility tests should be done before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to penicillin G. Therapy with Penicillin G Potassium for Injection may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the organisms listed below; however, once these results become available, appropriate therapy should be continued. To reduce the development of drug-resistant bacteria and maintain effectiveness of Penicillin G Potassium for Injection and other antibacterial drugs, Penicillin G Potassium 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": "Buffered Penicillin G Potassium for Injection, USP is a sterile, pyrogen-free powder for reconstitution. Buffered Penicillin G Potassium for Injection, USP is an antibacterial agent for intramuscular, continuous intravenous infusion, intrapleural or other local infusion, and intrathecal administration. Each million units contains approximately 6.8 milligrams of sodium (0.3 mEq) and 65.6 milligrams of potassium (1.68 mEq). Buffered Penicillin G Potassium for Injection, USP is supplied in vials equivalent to 5,000,000 units (5 million units) or 20,000,000 units (20 million units) of penicillin G as the potassium salt. Chemically, Penicillin G Potassium for Injection, USP is monopotassium 3,3-dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo (3.2.0) heptane-2-carboxylate. It has a molecular weight of 372.48 and the following chemical structure:. Penicillin G potassium is a colorless or white crystal, or a white crystalline powder which is odorless, or practically so, and moderately hygroscopic. Penicillin G potassium is very soluble in water. The pH of the reconstituted product is between 6.0 to 8.5."
},
{
"NDCCode": "83634-106-50",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (83634-106-50) / 20 mL in 1 VIAL, SINGLE-DOSE (83634-106-41) ",
"NDC11Code": "83634-0106-50",
"ProductNDC": "83634-106",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Piperacillin And Tazobactam",
"NonProprietaryName": "Piperacillin And Tazobactam",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065523",
"LabelerName": "Avenacy, LLC",
"SubstanceName": "PIPERACILLIN SODIUM; TAZOBACTAM SODIUM",
"StrengthNumber": "4; .5",
"StrengthUnit": "g/20mL; g/20mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250201",
"SamplePackage": "N",
"IndicationAndUsage": "Piperacillin and tazobactam for injection is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: : 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1) , 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2) , 3 Skin and skin structure infections in adults (1.3) , 4 Female pelvic infections in adults (1.4) , 5 Community-acquired pneumonia in adults (1.5) .",
"Description": "Piperacillin and Tazobactam for Injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is:. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is:. Piperacillin and Tazobactam for Injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Piperacillin and Tazobactam for Injection, USP, is a white to off-white sterile, lyophilized powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. This product does not contain excipients or preservatives. Each Piperacillin and Tazobactam for Injection, USP 2.25 gram single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 grams of tazobactam. Each vial contains 4.69 mEq (108 mg) of sodium. Each Piperacillin and Tazobactam for Injection, USP 3.375 gram single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 grams of tazobactam. Each vial contains 7.04 mEq (162 mg) of sodium. Each Piperacillin and Tazobactam for Injection, USP 4.5 gram single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 grams of tazobactam. Each vial contains 9.39 mEq (216 mg) of sodium. Meets USP Organic Impurities Test 3."
},
{
"NDCCode": "83634-107-20",
"PackageDescription": "1 VIAL in 1 CARTON (83634-107-20) / 10 mL in 1 VIAL",
"NDC11Code": "83634-0107-20",
"ProductNDC": "83634-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Daptomycin",
"NonProprietaryName": "Daptomycin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212022",
"LabelerName": "Avenacy Inc.",
"SubstanceName": "DAPTOMYCIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Lipopeptide Antibacterial [EPC], Lipopeptides [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20250115",
"SamplePackage": "N",
"IndicationAndUsage": "Daptomycin for Injection is a lipopeptide antibacterial indicated for the treatment of: : 1 Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) (1.1) and, , 2 Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis (1.2) , 3 Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age). (1.3) .",
"Description": "Daptomycin for Injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine Ɛ1- lactone. The chemical structure is:. The empirical formula is C72H101N17O26; the molecular weight is 1620.67. Daptomycin for Injection is supplied in a single-dose vial as a sterile, nonpyrogenic, preservative-free, pale yellow to light brown, lyophilized cake/powder containing approximately 500 mg of daptomycin for intravenous (IV) use following reconstitution with 0.9% sodium chloride injection [see Dosage and Administration (2.7)]. The only inactive ingredient is sodium hydroxide, which is used for pH adjustment. Freshly reconstituted solutions of Daptomycin for Injection range in color from pale yellow to light brown."
},
{
"NDCCode": "83634-109-20",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (83634-109-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (83634-109-41) ",
"NDC11Code": "83634-0109-20",
"ProductNDC": "83634-109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin And Sulbactam",
"NonProprietaryName": "Ampicillin And Sulbactam",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20250201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065222",
"LabelerName": "Avenacy, LLC",
"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": "Active",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250425",
"SamplePackage": "N",
"IndicationAndUsage": "Ampicillin and sulbactam for injection 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,* Klebsiella spp.* (including K. pneumoniae*), Proteus mirabilis,* Bacteroides fragilis,* Enterobacter spp.,* and Acinetobacter calcoaceticus.*. 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. pneumoniae*), Bacteroides spp. (including B. fragilis), and Enterobacter spp.*. Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli,* and Bacteroides spp.* (including B. fragilis*). * Efficacy for this organism in this organ system was studied in fewer than 10 infections. While ampicillin and sulbactam for injection 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 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 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. 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 and other antibacterial drugs, ampicillin and sulbactam for injection 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 grams of Ampicillin and Sulbactam for Injection, USP (1 gram ampicillin as the sodium salt plus 0.5 grams sulbactam as the sodium salt) parenteral contains approximately 115 mg (5 mEq) of sodium. 3 grams of Ampicillin and Sulbactam for Injection, USP (2 grams ampicillin as the sodium salt plus 1 gram sulbactam as the sodium salt) parenteral contains approximately 230 mg (10 mEq) of sodium."
},
{
"NDCCode": "83634-110-20",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (83634-110-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (83634-110-41) ",
"NDC11Code": "83634-0110-20",
"ProductNDC": "83634-110",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin And Sulbactam",
"NonProprietaryName": "Ampicillin And Sulbactam",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20250201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065222",
"LabelerName": "Avenacy, LLC",
"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": "Active",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250425",
"SamplePackage": "N",
"IndicationAndUsage": "Ampicillin and sulbactam for injection 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,* Klebsiella spp.* (including K. pneumoniae*), Proteus mirabilis,* Bacteroides fragilis,* Enterobacter spp.,* and Acinetobacter calcoaceticus.*. 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. pneumoniae*), Bacteroides spp. (including B. fragilis), and Enterobacter spp.*. Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli,* and Bacteroides spp.* (including B. fragilis*). * Efficacy for this organism in this organ system was studied in fewer than 10 infections. While ampicillin and sulbactam for injection 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 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 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. 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 and other antibacterial drugs, ampicillin and sulbactam for injection 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 grams of Ampicillin and Sulbactam for Injection, USP (1 gram ampicillin as the sodium salt plus 0.5 grams sulbactam as the sodium salt) parenteral contains approximately 115 mg (5 mEq) of sodium. 3 grams of Ampicillin and Sulbactam for Injection, USP (2 grams ampicillin as the sodium salt plus 1 gram sulbactam as the sodium salt) parenteral contains approximately 230 mg (10 mEq) of sodium."
},
{
"NDCCode": "83634-111-20",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (83634-111-20) / 10 mL in 1 VIAL, SINGLE-DOSE (83634-111-41) ",
"NDC11Code": "83634-0111-20",
"ProductNDC": "83634-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline",
"NonProprietaryName": "Doxycycline",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250301",
"EndMarketingDate": "20270130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217854",
"LabelerName": "Avenacy Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20250301",
"EndMarketingDatePackage": "20270130",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline for Injection, USP and other antibacterial drugs, Doxycycline 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. Doxycycline for Injection, USP is indicated in infections caused by the following microorganisms: : 1 Rickettsiae (Rocky Mountain spotted fever, typhus fever, and the typhus group, Q fever, rickettsial pox and tick fevers). , 2 Mycoplasma pneumoniae (PPLO, Eaton Agent). , 3 Agents of psittacosis and ornithosis. , 4 Agents of lymphogranuloma venereum and granuloma inguinale. , 5 The spirochetal agent of relapsing fever (Borrelia recurrentis). .",
"Description": "Doxycycline for injection, USP is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate (doxycycline hydrochloride hemiethanolate hemihydrate). The chemical designation of this yellowish crystalline powder is alpha-6-deoxy-5-oxytetracycline. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum."
},
{
"NDCCode": "83634-114-20",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (83634-114-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (83634-114-41) ",
"NDC11Code": "83634-0114-20",
"ProductNDC": "83634-114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS; ORAL",
"StartMarketingDate": "20260815",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210274",
"LabelerName": "Avenacy, LLC",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260815",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin Hydrochloride for Injection is a glycopeptide antibacterial indicated in adult and pediatric patients less than 18 years of age as follows: : 1 Vancomycin Hydrochloride for Injection administered intravenously is indicated for the treatment of:Septicemia (1.1) Infective Endocarditis (1.2) Skin and Skin Structure Infections (1.3) Bone Infections (1.4) Lower Respiratory Tract Infections (1.5) , 2 Vancomycin Hydrochloride for Injection administered orally is indicated for the treatment of:Clostridioides difficile-associated diarrhea (1.6) Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) (1.7) .",
"Description": "Vancomycin Hydrochloride for Injection contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S, 26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula:. Vancomycin Hydrochloride for Injection is a sterile, preservative-free, white, almost white to tan to brown, spray-dried powder, for preparing intravenous (IV) infusions, in single-dose vials each containing the equivalent of 500 mg, 750 mg, 1 gram, 1.25 grams or 1.5 grams vancomycin base. Each 500 mg vial contains 500 mg vancomycin (equivalent to 513 mg vancomycin hydrochloride), 125 mg trehalose, 0.05 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 750 mg vial contains 750 mg vancomycin (equivalent to 769 mg vancomycin hydrochloride), 187.5 mg trehalose, 0.075 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1 gram vial contains 1 gram vancomycin (equivalent to 1.025 grams vancomycin hydrochloride), 250 mg trehalose, 0.1 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.25 gram vial contains 1.25 grams vancomycin (equivalent to 1.28 grams vancomycin hydrochloride), 312.5 mg trehalose, 0.125 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.5 gram vial contains 1.5 grams vancomycin (equivalent to 1.54 grams vancomycin hydrochloride), 375 mg trehalose, 0.15 mg polysorbate 80, and hydrochloric acid used to adjust the pH. The spray-dried powder is reconstituted with Sterile Water for Injection which forms a clear solution and subsequently diluted prior to intravenous or oral administration [see Dosage and Administration (2.5, 2.8)]. Vancomycin Hydrochloride for Injection may also be diluted with a sweetening agent for oral administration [see Dosage and Administration (2.8)]."
},
{
"NDCCode": "83634-603-20",
"PackageDescription": "20 VIAL in 1 CARTON (83634-603-20) / 20 mL in 1 VIAL (83634-603-41) ",
"NDC11Code": "83634-0603-20",
"ProductNDC": "83634-603",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propofol",
"NonProprietaryName": "Propofol",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206408",
"LabelerName": "Avenacy, LLC",
"SubstanceName": "PROPOFOL",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: : 1 Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age , 2 Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age , 3 Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients , 4 Sedation for Adult Patients in Combination with Regional Anesthesia , 5 Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients .",
"Description": "Propofol injectable emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white homogeneous emulsion for intravenous administration. The structural formula is:. Chemical name: 2,6 diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.27. Propofol, USP is slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. Each mL of propofol injectable emulsion, USP contains 10 mg of propofol USP, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerol (22.5 mg/mL), 12 mg of purified egg phospholipids (12 mg/mL), 0.055 mg of disodium edetate anhydrous (equivalent to 0.055 mg of disodium edetate) (0.05 mg/mL) as microbial inhibitor, and sodium hydroxide to adjust pH, in water for injection. Propofol injectable emulsion, USP is isotonic and has a pH of 6.0 to 8.5."
},
{
"NDCCode": "83634-603-50",
"PackageDescription": "20 VIAL in 1 CARTON (83634-603-50) / 50 mL in 1 VIAL (83634-603-42) ",
"NDC11Code": "83634-0603-50",
"ProductNDC": "83634-603",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propofol",
"NonProprietaryName": "Propofol",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206408",
"LabelerName": "Avenacy, LLC",
"SubstanceName": "PROPOFOL",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: : 1 Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age , 2 Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age , 3 Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients , 4 Sedation for Adult Patients in Combination with Regional Anesthesia , 5 Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients .",
"Description": "Propofol injectable emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white homogeneous emulsion for intravenous administration. The structural formula is:. Chemical name: 2,6 diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.27. Propofol, USP is slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. Each mL of propofol injectable emulsion, USP contains 10 mg of propofol USP, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerol (22.5 mg/mL), 12 mg of purified egg phospholipids (12 mg/mL), 0.055 mg of disodium edetate anhydrous (equivalent to 0.055 mg of disodium edetate) (0.05 mg/mL) as microbial inhibitor, and sodium hydroxide to adjust pH, in water for injection. Propofol injectable emulsion, USP is isotonic and has a pH of 6.0 to 8.5."
},
{
"NDCCode": "83634-651-20",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (83634-651-20) / 20 mL in 1 VIAL, MULTI-DOSE (83634-651-42) ",
"NDC11Code": "83634-0651-20",
"ProductNDC": "83634-651",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INFILTRATION; PERINEURAL",
"StartMarketingDate": "20250701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219535",
"LabelerName": "Avenacy, LLC",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260215",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine hydrochloride injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of lidocaine hydrochloride injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].",
"Description": "Lidocaine hydrochloride injection, USP contains lidocaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for lidocaine hydrochloride injection, USP is by injection, for infiltration, nerve block, epidural and caudal use. Multiple dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks. Dosage forms listed as lidocaine hydrochloride injection, USP – MPF indicate single-dose solutions that are Methylparaben Free (MPF). Lidocaine hydrochloride, is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride monohydrate and has the molecular weight of 288.8 g/mol. Lidocaine hydrochloride molecular formula is C14H22N2O HClH2O, and has the following structural formula:. Lidocaine hydrochloride injection, USP in multiple dose vials is a sterile, nonpyrogenic, isotonic, clear, colorless solution containing lidocaine hydrochloride and sodium chloride. Each mL contains 1 mg methylparaben as an antiseptic preservative. The pH of these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and hydrochloric acid. Lidocaine hydrochloride injection, USP - MPF is a sterile, nonpyrogenic, isotonic, clear, colorless, and preservative-free solution. The pH of these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and hydrochloric acid."
},
{
"NDCCode": "83634-655-20",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (83634-655-20) / 20 mL in 1 VIAL, SINGLE-DOSE (83634-655-41) ",
"NDC11Code": "83634-0655-20",
"ProductNDC": "83634-655",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cisatracurium Besylate",
"NonProprietaryName": "Cisatracurium Besylate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216539",
"LabelerName": "Avenacy, LLC",
"SubstanceName": "CISATRACURIUM BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260815",
"SamplePackage": "N",
"IndicationAndUsage": "Cisatracurium Besylate Injection is indicated: : 1 as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age , 2 to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU , 3 to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older .",
"Description": "Cisatracurium Besylate Injection (cisatracurium besylate), USP is a nondepolarizing skeletal neuromuscular blocker for intravenous administration. Compared to other neuromuscular blockers, it is intermediate in its onset and duration of action. Cisatracurium besylate is one of 10 isomers of atracurium besylate and constitutes approximately 15% of that mixture. Cisatracurium besylate is [1R-[1α,2α(1'R*,2'R*)]]-2,2'-[1,5-pentanediylbis[oxy(3-oxo-3,1-propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinolinium] dibenzenesulfonate. The molecular formula of the cisatracurium parent bis-cation is C53H72N2O12 and the molecular weight is 929.2. The molecular formula of cisatracurium as the besylate salt is C65H82N2O18S2 and the molecular weight is 1243.50. The structural formula of cisatracurium besylate is:. The log of the partition coefficient of cisatracurium besylate is -2.12 in a 1-octanol/distilled water system at 25°C. Cisatracurium Besylate Injection, USP is a sterile, non-pyrogenic aqueous solution. Each mL in the single-dose vials contains 10 mg of cisatracurium (equivalent to 13.38 mg of cisatracurium besylate), and benzenesulfonic acid as pH adjuster in water for injection. The pH of cisatracurium besylate is between 3.0 and 3.8."
},
{
"NDCCode": "12714-104-20",
"PackageDescription": "20 mg in 1 BAG (12714-104-20) ",
"NDC11Code": "12714-0104-20",
"ProductNDC": "12714-104",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Tremelimumab",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20221021",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Boehringer Ingelheim Pharma GmbH and Co. KG",
"SubstanceName": "TREMELIMUMAB",
"StrengthNumber": "20",
"StrengthUnit": "mg/20mg",
"Status": "Unfinished",
"LastUpdate": "2024-05-23",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "21-OCT-22"
},
{
"NDCCode": "15343-104-20",
"PackageDescription": "1 KIT in 1 CARTON (15343-104-20) * 20 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "15343-0104-20",
"ProductNDC": "15343-104",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Prime Asthma Relief",
"NonProprietaryName": "Epinephrine",
"DosageFormName": "KIT",
"StartMarketingDate": "20140821",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "DRNATURALHEALING",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For temporary relief of mild symptoms of intermittent asthma: 1 wheezing, 2 tightness of chest, 3 shortness of breath."
},
{
"NDCCode": "16812-104-09",
"PackageDescription": "1 BAG in 1 BAG (16812-104-09) / 20 g in 1 BAG",
"NDC11Code": "16812-0104-09",
"ProductNDC": "16812-104",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Tirzepatide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20241016",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Aurisco Pharmaceutical Co.,Ltd",
"SubstanceName": "TIRZEPATIDE",
"StrengthNumber": "20",
"StrengthUnit": "g/20g",
"Status": "Unfinished",
"LastUpdate": "2025-09-13",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "16-OCT-24"
},
{
"NDCCode": "24909-104-20",
"PackageDescription": "200 g in 1 JAR (24909-104-20) ",
"NDC11Code": "24909-0104-20",
"ProductNDC": "24909-104",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Terrasil Tinea Treatment",
"ProprietaryNameSuffix": "Max",
"NonProprietaryName": "Clotrimazole",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140512",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M005",
"LabelerName": "Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions",
"SubstanceName": "CLOTRIMAZOLE",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2025-07-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140512",
"SamplePackage": "N",
"IndicationAndUsage": "Proven clinically effective in the treatment of athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). For effective relief of itching, irritation, redness, scaling, cracking, burning, soreness, and discomfort which can accompany these conditions."
},
{
"NDCCode": "33261-104-20",
"PackageDescription": "20 TABLET in 1 BOTTLE (33261-104-20)",
"NDC11Code": "33261-0104-20",
"ProductNDC": "33261-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine",
"NonProprietaryName": "Tizanidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020703",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076286",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Tizanidine tablets are a short-acting drug for the management of spasticity. Because of the short duration of effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important (see DOSAGE AND ADMINISTRATION).",
"Description": "Tizanidine hydrochloride USP, is a centrally acting α2-adrenergic agonist. Tizanidine HCl USP (tizanidine) is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiodiazole hydrochloride. Tizanidine’s molecular formula is C9H8ClN5S.HCl, its molecular weight is 290.2 and its structural formula is. Tizanidine tablets USP, is supplied as 2 mg and 4 mg tablets for oral administration. Tizanidine tablets USP, are composed of the active ingredient, tizanidine hydrochloride USP (2.29 mg equivalent to 2 mg tizanidine base and 4.58 mg equivalent to 4 mg tizanidine base), and the inactive ingredients, anhydrous lactose, microcrystalline cellulose, colloidal silicon dioxide and stearic acid."
},
{
"NDCCode": "43624-043-01",
"PackageDescription": "3 TRAY in 1 BOX (43624-043-01) / 104 VIAL in 1 TRAY / 20 mL in 1 VIAL",
"NDC11Code": "43624-0043-01",
"ProductNDC": "43624-043",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Polatuzumab Vedotin Lyophilized Vials 140 Mg",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"StartMarketingDate": "20190610",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "BSP Pharmaceuticals S.p.A.",
"SubstanceName": "POLATUZUMAB VEDOTIN",
"StrengthNumber": "140",
"StrengthUnit": "mg/7.52mL",
"Status": "Unfinished",
"LastUpdate": "2026-05-11",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "06-OCT-19"
},
{
"NDCCode": "51079-104-20",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-104-20) > 1 TABLET in 1 BLISTER PACK (51079-104-01)",
"NDC11Code": "51079-0104-20",
"ProductNDC": "51079-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spironolactone And Hydrochlorothiazide",
"NonProprietaryName": "Spironolactone And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19940411",
"EndMarketingDate": "20181130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086513",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "SPIRONOLACTONE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "25; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-12-02",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "51346-104-01",
"PackageDescription": "20 mL in 1 CARTON (51346-104-01)",
"NDC11Code": "51346-0104-01",
"ProductNDC": "51346-104",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Essential Solution Caviar Mask Sheet",
"NonProprietaryName": "Glycerin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "NATURE REPUBLIC CO., LTD.",
"SubstanceName": "GLYCERIN",
"StrengthNumber": "4",
"StrengthUnit": "g/20mL",
"Status": "Deprecated",
"LastUpdate": "2018-10-25",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "51414-104-07",
"PackageDescription": "20 g in 1 PACKAGE (51414-104-07) ",
"NDC11Code": "51414-0104-07",
"ProductNDC": "51414-104",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Spf30 Sunscreen",
"NonProprietaryName": "Octinoxate,oxybenzone,octisalate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120912",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Yuyao Jessie Commodity Co.,Ltd.",
"SubstanceName": "OCTINOXATE; OCTISALATE; OXYBENZONE",
"StrengthNumber": "7.5; 4; 4",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-02-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20161211",
"SamplePackage": "N",
"IndicationAndUsage": "hellps prevent sunburn. if used as directed with other sun protection measures(see Dirctions),decreases the rish of skin cancer and early skin aging carsed by the sun."
},
{
"NDCCode": "51414-104-20",
"PackageDescription": "160 g in 1 PACKAGE (51414-104-20) ",
"NDC11Code": "51414-0104-20",
"ProductNDC": "51414-104",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Spf30 Sunscreen",
"NonProprietaryName": "Octinoxate,oxybenzone,octisalate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120912",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Yuyao Jessie Commodity Co.,Ltd.",
"SubstanceName": "OCTINOXATE; OCTISALATE; OXYBENZONE",
"StrengthNumber": "7.5; 4; 4",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-02-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20161211",
"SamplePackage": "N",
"IndicationAndUsage": "hellps prevent sunburn. if used as directed with other sun protection measures(see Dirctions),decreases the rish of skin cancer and early skin aging carsed by the sun."
},
{
"NDCCode": "52584-104-20",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BAG (52584-104-20) > 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "52584-0104-20",
"ProductNDC": "52584-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dopamine Hydrochloride",
"NonProprietaryName": "Dopamine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20100801",
"EndMarketingDate": "20230201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018132",
"LabelerName": "General Injectables & Vaccines, Inc",
"SubstanceName": "DOPAMINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Catecholamine [EPC], Catecholamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100801",
"EndMarketingDatePackage": "20230201",
"SamplePackage": "N"
},
{
"NDCCode": "54157-104-20",
"PackageDescription": "85 g in 1 TUBE (54157-104-20)",
"NDC11Code": "54157-0104-20",
"ProductNDC": "54157-104",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Megafresh",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20140511",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "American Amenities, Inc.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".15",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses: Aids in the prevention of dental cavities."
},
{
"NDCCode": "57896-104-20",
"PackageDescription": "200 TABLET in 1 BOTTLE (57896-104-20) ",
"NDC11Code": "57896-0104-20",
"ProductNDC": "57896-104",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Regular Strength Pain Relief",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Geri-Care Pharmaceutical Corp",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200401",
"SamplePackage": "N",
"IndicationAndUsage": ": 1 temporarily relieves minor aches and pains , 2 temporarily reduces fever."
},
{
"NDCCode": "58159-104-02",
"PackageDescription": "20 kg in 1 DRUM (58159-104-02) ",
"NDC11Code": "58159-0104-02",
"ProductNDC": "58159-104",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Nicotinamide Riboside Chloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20240821",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "NURAY CHEMICALS PRIVATE LIMITED",
"SubstanceName": "NICOTINAMIDE RIBOSIDE CHLORIDE",
"StrengthNumber": "35",
"StrengthUnit": "kg/35kg",
"Status": "Unfinished",
"LastUpdate": "2024-08-30",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "21-AUG-24"
},
{
"NDCCode": "59316-104-20",
"PackageDescription": "118 mL in 1 BOTTLE, SPRAY (59316-104-20) ",
"NDC11Code": "59316-0104-20",
"ProductNDC": "59316-104",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Biofreeze",
"NonProprietaryName": "Menthol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20101101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Reckitt Benckiser LLC",
"SubstanceName": "MENTHOL, UNSPECIFIED FORM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160825",
"SamplePackage": "N",
"IndicationAndUsage": "Temporary relief from minor aches and pains of sore muscles and joints associated with: -arthritis - backache - strains - sprains."
},
{
"NDCCode": "61476-104-20",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (61476-104-20) / 200 mL in 1 VIAL, GLASS (61476-104-03) ",
"NDC11Code": "61476-0104-20",
"ProductNDC": "61476-104",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Alyglo",
"NonProprietaryName": "Human Immunoglobulin G",
"DosageFormName": "LIQUID",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20231215",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125743",
"LabelerName": "GC Biopharma Corp.",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231215",
"SamplePackage": "N",
"IndicationAndUsage": "ALYGLO (immune globulin intravenous, human-stwk) is a 10% immune globulin liquid for intravenous injection, indicated for the treatment of primary humoral immunodeficiency (PI) in adults. This includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiency (SCID).",
"Description": "ALYGLO (immune globulin intravenous, human-stwk) is a ready-to-use, sterile, liquid preparation of highly purified and concentrated human immunoglobulin G (IgG) antibodies. The product is a clear or slightly opalescent liquid, which is colorless or pale yellow. The distribution of the IgG subclasses is similar to that of normal human plasma. The active ingredient is human immunoglobulin G purified from human Source Plasma and processed using a modified Cohn-Oncley fractionation process, as well as anion and cation exchange chromatography. ALYGLO contains 100 mg/mL protein, of which not less than ≥ 96% is human IgG obtained from human Source Plasma. It is formulated with glycine targeted at 18.8 mg/mL (15.0 – 22.6 mg/mL) as a stabilizer and water for injection as a solvent with pH in the range of 4.5 – 5.5. ALYGLO contains ≤ 20 mcg/mL of IgA. The osmolality is in the range of 240-360 mOsmol/kg, which is similar to physiological osmolality (average 275 to 295 mOsmol/kg). There are no added sugars, sodium or preservatives. All plasma units used in the manufacture of ALYGLO have been tested and approved for manufacture using FDA-licensed serological assays for human hepatitis B surface antigen (HBsAg) and antibodies to human hepatitis C virus (anti-HCV) and human immunodeficiency virus types 1 and 2 (anti-HIV-1/2) as well as FDA-licensed Nucleic Acid Testing (NAT) for HIV-1, HAV, HBV, and HCV and found to be non-reactive (negative). In addition, the plasma has been tested for human parvovirus B19 by NAT. Only plasma that passed virus screening is used for production, and the limit for human parvovirus B19 in the manufacturing plasma pool is set not to exceed 10,000 IU/mL. The manufacturing process for ALYGLO includes three steps to reduce the risk of virus transmission. The steps are “Fractionation I+III, solvent/detergent (S/D) treatment, and Nanofiltration.”. The steps of Fractionation I+III and Nanofiltration (20 nm) remove both enveloped and non-enveloped viruses, and the S/D treatment step inactivates enveloped viruses. The results of virus validation studies for ALYGLO are shown in Table 3, expressed as log10 reduction factor (LRF). NT: Not Tested. 1 Enveloped viruses. 2 Non-enveloped viruses. HIV-1: Human Immunodeficiency virus type 1, a model for HIV-1 and HIV-2, PRV: Pseudorabies virus, a model for large enveloped DNA viruses (e.g., herpes virus); BVDV: Bovine viral diarrhea virus a model for e.g., Hepatitis C virus (HCV) and West Nile virus (WNV); EMCV: Encephalomyocarditis virus, a model for Hepatitis A virus (HAV); PPV: Porcine parvovirus, a model for Human Parvovirus B19."
},
{
"NDCCode": "62135-104-20",
"PackageDescription": "20 TABLET, CHEWABLE in 1 BOTTLE (62135-104-20) ",
"NDC11Code": "62135-0104-20",
"ProductNDC": "62135-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20050322",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065205",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "200; 28.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260721",
"SamplePackage": "N"
},
{
"NDCCode": "64220-104-07",
"PackageDescription": "20 kg in 1 DRUM (64220-104-07)",
"NDC11Code": "64220-0104-07",
"ProductNDC": "64220-104",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Carvedilol Phosphate Hemihydrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20080630",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>83634-104-20</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (83634-104-20) / 10 mL in 1 VIAL, SINGLE-DOSE (83634-104-41) </PackageDescription>
<NDC11Code>83634-0104-20</NDC11Code>
<ProductNDC>83634-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Piperacillin And Tazobactam</ProprietaryName>
<NonProprietaryName>Piperacillin And Tazobactam</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065523</ApplicationNumber>
<LabelerName>Avenacy, LLC</LabelerName>
<SubstanceName>PIPERACILLIN SODIUM; TAZOBACTAM SODIUM</SubstanceName>
<StrengthNumber>2; .25</StrengthNumber>
<StrengthUnit>g/10mL; g/10mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Piperacillin and tazobactam for injection is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: : 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1) , 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2) , 3 Skin and skin structure infections in adults (1.3) , 4 Female pelvic infections in adults (1.4) , 5 Community-acquired pneumonia in adults (1.5) .</IndicationAndUsage>
<Description>Piperacillin and Tazobactam for Injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is:. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is:. Piperacillin and Tazobactam for Injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Piperacillin and Tazobactam for Injection, USP, is a white to off-white sterile, lyophilized powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. This product does not contain excipients or preservatives. Each Piperacillin and Tazobactam for Injection, USP 2.25 gram single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 grams of tazobactam. Each vial contains 4.69 mEq (108 mg) of sodium. Each Piperacillin and Tazobactam for Injection, USP 3.375 gram single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 grams of tazobactam. Each vial contains 7.04 mEq (162 mg) of sodium. Each Piperacillin and Tazobactam for Injection, USP 4.5 gram single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 grams of tazobactam. Each vial contains 9.39 mEq (216 mg) of sodium. Meets USP Organic Impurities Test 3.</Description>
</NDC>
<NDC>
<NDCCode>83634-102-20</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (83634-102-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (83634-102-41) </PackageDescription>
<NDC11Code>83634-0102-20</NDC11Code>
<ProductNDC>83634-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Penicillin G Potassium</ProprietaryName>
<NonProprietaryName>Penicillin G Potassium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20250201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065448</ApplicationNumber>
<LabelerName>Avenacy Inc.</LabelerName>
<SubstanceName>PENICILLIN G POTASSIUM</SubstanceName>
<StrengthNumber>5000000</StrengthNumber>
<StrengthUnit>[iU]/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Penicillin G Potassium for Injection is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Appropriate culture and susceptibility tests should be done before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to penicillin G. Therapy with Penicillin G Potassium for Injection may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the organisms listed below; however, once these results become available, appropriate therapy should be continued. To reduce the development of drug-resistant bacteria and maintain effectiveness of Penicillin G Potassium for Injection and other antibacterial drugs, Penicillin G Potassium 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>Buffered Penicillin G Potassium for Injection, USP is a sterile, pyrogen-free powder for reconstitution. Buffered Penicillin G Potassium for Injection, USP is an antibacterial agent for intramuscular, continuous intravenous infusion, intrapleural or other local infusion, and intrathecal administration. Each million units contains approximately 6.8 milligrams of sodium (0.3 mEq) and 65.6 milligrams of potassium (1.68 mEq). Buffered Penicillin G Potassium for Injection, USP is supplied in vials equivalent to 5,000,000 units (5 million units) or 20,000,000 units (20 million units) of penicillin G as the potassium salt. Chemically, Penicillin G Potassium for Injection, USP is monopotassium 3,3-dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo (3.2.0) heptane-2-carboxylate. It has a molecular weight of 372.48 and the following chemical structure:. Penicillin G potassium is a colorless or white crystal, or a white crystalline powder which is odorless, or practically so, and moderately hygroscopic. Penicillin G potassium is very soluble in water. The pH of the reconstituted product is between 6.0 to 8.5.</Description>
</NDC>
<NDC>
<NDCCode>83634-106-50</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (83634-106-50) / 20 mL in 1 VIAL, SINGLE-DOSE (83634-106-41) </PackageDescription>
<NDC11Code>83634-0106-50</NDC11Code>
<ProductNDC>83634-106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Piperacillin And Tazobactam</ProprietaryName>
<NonProprietaryName>Piperacillin And Tazobactam</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065523</ApplicationNumber>
<LabelerName>Avenacy, LLC</LabelerName>
<SubstanceName>PIPERACILLIN SODIUM; TAZOBACTAM SODIUM</SubstanceName>
<StrengthNumber>4; .5</StrengthNumber>
<StrengthUnit>g/20mL; g/20mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Piperacillin and tazobactam for injection is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: : 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1) , 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2) , 3 Skin and skin structure infections in adults (1.3) , 4 Female pelvic infections in adults (1.4) , 5 Community-acquired pneumonia in adults (1.5) .</IndicationAndUsage>
<Description>Piperacillin and Tazobactam for Injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is:. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is:. Piperacillin and Tazobactam for Injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Piperacillin and Tazobactam for Injection, USP, is a white to off-white sterile, lyophilized powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. This product does not contain excipients or preservatives. Each Piperacillin and Tazobactam for Injection, USP 2.25 gram single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 grams of tazobactam. Each vial contains 4.69 mEq (108 mg) of sodium. Each Piperacillin and Tazobactam for Injection, USP 3.375 gram single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 grams of tazobactam. Each vial contains 7.04 mEq (162 mg) of sodium. Each Piperacillin and Tazobactam for Injection, USP 4.5 gram single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 grams of tazobactam. Each vial contains 9.39 mEq (216 mg) of sodium. Meets USP Organic Impurities Test 3.</Description>
</NDC>
<NDC>
<NDCCode>83634-107-20</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (83634-107-20) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>83634-0107-20</NDC11Code>
<ProductNDC>83634-107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Daptomycin</ProprietaryName>
<NonProprietaryName>Daptomycin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212022</ApplicationNumber>
<LabelerName>Avenacy Inc.</LabelerName>
<SubstanceName>DAPTOMYCIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Lipopeptide Antibacterial [EPC], Lipopeptides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Daptomycin for Injection is a lipopeptide antibacterial indicated for the treatment of: : 1 Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) (1.1) and, , 2 Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis (1.2) , 3 Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age). (1.3) .</IndicationAndUsage>
<Description>Daptomycin for Injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine Ɛ1- lactone. The chemical structure is:. The empirical formula is C72H101N17O26; the molecular weight is 1620.67. Daptomycin for Injection is supplied in a single-dose vial as a sterile, nonpyrogenic, preservative-free, pale yellow to light brown, lyophilized cake/powder containing approximately 500 mg of daptomycin for intravenous (IV) use following reconstitution with 0.9% sodium chloride injection [see Dosage and Administration (2.7)]. The only inactive ingredient is sodium hydroxide, which is used for pH adjustment. Freshly reconstituted solutions of Daptomycin for Injection range in color from pale yellow to light brown.</Description>
</NDC>
<NDC>
<NDCCode>83634-109-20</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (83634-109-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (83634-109-41) </PackageDescription>
<NDC11Code>83634-0109-20</NDC11Code>
<ProductNDC>83634-109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin And Sulbactam</ProprietaryName>
<NonProprietaryName>Ampicillin And Sulbactam</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20250201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065222</ApplicationNumber>
<LabelerName>Avenacy, LLC</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>Active</Status>
<LastUpdate>2025-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ampicillin and sulbactam for injection 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,* Klebsiella spp.* (including K. pneumoniae*), Proteus mirabilis,* Bacteroides fragilis,* Enterobacter spp.,* and Acinetobacter calcoaceticus.*. 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. pneumoniae*), Bacteroides spp. (including B. fragilis), and Enterobacter spp.*. Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli,* and Bacteroides spp.* (including B. fragilis*). * Efficacy for this organism in this organ system was studied in fewer than 10 infections. While ampicillin and sulbactam for injection 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 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 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. 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 and other antibacterial drugs, ampicillin and sulbactam for injection 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 grams of Ampicillin and Sulbactam for Injection, USP (1 gram ampicillin as the sodium salt plus 0.5 grams sulbactam as the sodium salt) parenteral contains approximately 115 mg (5 mEq) of sodium. 3 grams of Ampicillin and Sulbactam for Injection, USP (2 grams ampicillin as the sodium salt plus 1 gram sulbactam as the sodium salt) parenteral contains approximately 230 mg (10 mEq) of sodium.</Description>
</NDC>
<NDC>
<NDCCode>83634-110-20</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (83634-110-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (83634-110-41) </PackageDescription>
<NDC11Code>83634-0110-20</NDC11Code>
<ProductNDC>83634-110</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin And Sulbactam</ProprietaryName>
<NonProprietaryName>Ampicillin And Sulbactam</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20250201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065222</ApplicationNumber>
<LabelerName>Avenacy, LLC</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>Active</Status>
<LastUpdate>2025-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ampicillin and sulbactam for injection 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,* Klebsiella spp.* (including K. pneumoniae*), Proteus mirabilis,* Bacteroides fragilis,* Enterobacter spp.,* and Acinetobacter calcoaceticus.*. 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. pneumoniae*), Bacteroides spp. (including B. fragilis), and Enterobacter spp.*. Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli,* and Bacteroides spp.* (including B. fragilis*). * Efficacy for this organism in this organ system was studied in fewer than 10 infections. While ampicillin and sulbactam for injection 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 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 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. 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 and other antibacterial drugs, ampicillin and sulbactam for injection 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 grams of Ampicillin and Sulbactam for Injection, USP (1 gram ampicillin as the sodium salt plus 0.5 grams sulbactam as the sodium salt) parenteral contains approximately 115 mg (5 mEq) of sodium. 3 grams of Ampicillin and Sulbactam for Injection, USP (2 grams ampicillin as the sodium salt plus 1 gram sulbactam as the sodium salt) parenteral contains approximately 230 mg (10 mEq) of sodium.</Description>
</NDC>
<NDC>
<NDCCode>83634-111-20</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (83634-111-20) / 10 mL in 1 VIAL, SINGLE-DOSE (83634-111-41) </PackageDescription>
<NDC11Code>83634-0111-20</NDC11Code>
<ProductNDC>83634-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<NonProprietaryName>Doxycycline</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250301</StartMarketingDate>
<EndMarketingDate>20270130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217854</ApplicationNumber>
<LabelerName>Avenacy Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20250301</StartMarketingDatePackage>
<EndMarketingDatePackage>20270130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline for Injection, USP and other antibacterial drugs, Doxycycline 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. Doxycycline for Injection, USP is indicated in infections caused by the following microorganisms: : 1 Rickettsiae (Rocky Mountain spotted fever, typhus fever, and the typhus group, Q fever, rickettsial pox and tick fevers). , 2 Mycoplasma pneumoniae (PPLO, Eaton Agent). , 3 Agents of psittacosis and ornithosis. , 4 Agents of lymphogranuloma venereum and granuloma inguinale. , 5 The spirochetal agent of relapsing fever (Borrelia recurrentis). .</IndicationAndUsage>
<Description>Doxycycline for injection, USP is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate (doxycycline hydrochloride hemiethanolate hemihydrate). The chemical designation of this yellowish crystalline powder is alpha-6-deoxy-5-oxytetracycline. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum.</Description>
</NDC>
<NDC>
<NDCCode>83634-114-20</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (83634-114-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (83634-114-41) </PackageDescription>
<NDC11Code>83634-0114-20</NDC11Code>
<ProductNDC>83634-114</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; ORAL</RouteName>
<StartMarketingDate>20260815</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210274</ApplicationNumber>
<LabelerName>Avenacy, LLC</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin Hydrochloride for Injection is a glycopeptide antibacterial indicated in adult and pediatric patients less than 18 years of age as follows: : 1 Vancomycin Hydrochloride for Injection administered intravenously is indicated for the treatment of:Septicemia (1.1) Infective Endocarditis (1.2) Skin and Skin Structure Infections (1.3) Bone Infections (1.4) Lower Respiratory Tract Infections (1.5) , 2 Vancomycin Hydrochloride for Injection administered orally is indicated for the treatment of:Clostridioides difficile-associated diarrhea (1.6) Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) (1.7) .</IndicationAndUsage>
<Description>Vancomycin Hydrochloride for Injection contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S, 26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula:. Vancomycin Hydrochloride for Injection is a sterile, preservative-free, white, almost white to tan to brown, spray-dried powder, for preparing intravenous (IV) infusions, in single-dose vials each containing the equivalent of 500 mg, 750 mg, 1 gram, 1.25 grams or 1.5 grams vancomycin base. Each 500 mg vial contains 500 mg vancomycin (equivalent to 513 mg vancomycin hydrochloride), 125 mg trehalose, 0.05 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 750 mg vial contains 750 mg vancomycin (equivalent to 769 mg vancomycin hydrochloride), 187.5 mg trehalose, 0.075 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1 gram vial contains 1 gram vancomycin (equivalent to 1.025 grams vancomycin hydrochloride), 250 mg trehalose, 0.1 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.25 gram vial contains 1.25 grams vancomycin (equivalent to 1.28 grams vancomycin hydrochloride), 312.5 mg trehalose, 0.125 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.5 gram vial contains 1.5 grams vancomycin (equivalent to 1.54 grams vancomycin hydrochloride), 375 mg trehalose, 0.15 mg polysorbate 80, and hydrochloric acid used to adjust the pH. The spray-dried powder is reconstituted with Sterile Water for Injection which forms a clear solution and subsequently diluted prior to intravenous or oral administration [see Dosage and Administration (2.5, 2.8)]. Vancomycin Hydrochloride for Injection may also be diluted with a sweetening agent for oral administration [see Dosage and Administration (2.8)].</Description>
</NDC>
<NDC>
<NDCCode>83634-603-20</NDCCode>
<PackageDescription>20 VIAL in 1 CARTON (83634-603-20) / 20 mL in 1 VIAL (83634-603-41) </PackageDescription>
<NDC11Code>83634-0603-20</NDC11Code>
<ProductNDC>83634-603</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propofol</ProprietaryName>
<NonProprietaryName>Propofol</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206408</ApplicationNumber>
<LabelerName>Avenacy, LLC</LabelerName>
<SubstanceName>PROPOFOL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: : 1 Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age , 2 Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age , 3 Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients , 4 Sedation for Adult Patients in Combination with Regional Anesthesia , 5 Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients .</IndicationAndUsage>
<Description>Propofol injectable emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white homogeneous emulsion for intravenous administration. The structural formula is:. Chemical name: 2,6 diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.27. Propofol, USP is slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. Each mL of propofol injectable emulsion, USP contains 10 mg of propofol USP, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerol (22.5 mg/mL), 12 mg of purified egg phospholipids (12 mg/mL), 0.055 mg of disodium edetate anhydrous (equivalent to 0.055 mg of disodium edetate) (0.05 mg/mL) as microbial inhibitor, and sodium hydroxide to adjust pH, in water for injection. Propofol injectable emulsion, USP is isotonic and has a pH of 6.0 to 8.5.</Description>
</NDC>
<NDC>
<NDCCode>83634-603-50</NDCCode>
<PackageDescription>20 VIAL in 1 CARTON (83634-603-50) / 50 mL in 1 VIAL (83634-603-42) </PackageDescription>
<NDC11Code>83634-0603-50</NDC11Code>
<ProductNDC>83634-603</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propofol</ProprietaryName>
<NonProprietaryName>Propofol</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206408</ApplicationNumber>
<LabelerName>Avenacy, LLC</LabelerName>
<SubstanceName>PROPOFOL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: : 1 Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age , 2 Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age , 3 Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients , 4 Sedation for Adult Patients in Combination with Regional Anesthesia , 5 Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients .</IndicationAndUsage>
<Description>Propofol injectable emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white homogeneous emulsion for intravenous administration. The structural formula is:. Chemical name: 2,6 diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.27. Propofol, USP is slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. Each mL of propofol injectable emulsion, USP contains 10 mg of propofol USP, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerol (22.5 mg/mL), 12 mg of purified egg phospholipids (12 mg/mL), 0.055 mg of disodium edetate anhydrous (equivalent to 0.055 mg of disodium edetate) (0.05 mg/mL) as microbial inhibitor, and sodium hydroxide to adjust pH, in water for injection. Propofol injectable emulsion, USP is isotonic and has a pH of 6.0 to 8.5.</Description>
</NDC>
<NDC>
<NDCCode>83634-651-20</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (83634-651-20) / 20 mL in 1 VIAL, MULTI-DOSE (83634-651-42) </PackageDescription>
<NDC11Code>83634-0651-20</NDC11Code>
<ProductNDC>83634-651</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INFILTRATION; PERINEURAL</RouteName>
<StartMarketingDate>20250701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219535</ApplicationNumber>
<LabelerName>Avenacy, LLC</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine hydrochloride injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of lidocaine hydrochloride injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>Lidocaine hydrochloride injection, USP contains lidocaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for lidocaine hydrochloride injection, USP is by injection, for infiltration, nerve block, epidural and caudal use. Multiple dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks. Dosage forms listed as lidocaine hydrochloride injection, USP – MPF indicate single-dose solutions that are Methylparaben Free (MPF). Lidocaine hydrochloride, is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride monohydrate and has the molecular weight of 288.8 g/mol. Lidocaine hydrochloride molecular formula is C14H22N2O HClH2O, and has the following structural formula:. Lidocaine hydrochloride injection, USP in multiple dose vials is a sterile, nonpyrogenic, isotonic, clear, colorless solution containing lidocaine hydrochloride and sodium chloride. Each mL contains 1 mg methylparaben as an antiseptic preservative. The pH of these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and hydrochloric acid. Lidocaine hydrochloride injection, USP - MPF is a sterile, nonpyrogenic, isotonic, clear, colorless, and preservative-free solution. The pH of these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and hydrochloric acid.</Description>
</NDC>
<NDC>
<NDCCode>83634-655-20</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (83634-655-20) / 20 mL in 1 VIAL, SINGLE-DOSE (83634-655-41) </PackageDescription>
<NDC11Code>83634-0655-20</NDC11Code>
<ProductNDC>83634-655</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cisatracurium Besylate</ProprietaryName>
<NonProprietaryName>Cisatracurium Besylate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216539</ApplicationNumber>
<LabelerName>Avenacy, LLC</LabelerName>
<SubstanceName>CISATRACURIUM BESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cisatracurium Besylate Injection is indicated: : 1 as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age , 2 to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU , 3 to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older .</IndicationAndUsage>
<Description>Cisatracurium Besylate Injection (cisatracurium besylate), USP is a nondepolarizing skeletal neuromuscular blocker for intravenous administration. Compared to other neuromuscular blockers, it is intermediate in its onset and duration of action. Cisatracurium besylate is one of 10 isomers of atracurium besylate and constitutes approximately 15% of that mixture. Cisatracurium besylate is [1R-[1α,2α(1'R*,2'R*)]]-2,2'-[1,5-pentanediylbis[oxy(3-oxo-3,1-propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinolinium] dibenzenesulfonate. The molecular formula of the cisatracurium parent bis-cation is C53H72N2O12 and the molecular weight is 929.2. The molecular formula of cisatracurium as the besylate salt is C65H82N2O18S2 and the molecular weight is 1243.50. The structural formula of cisatracurium besylate is:. The log of the partition coefficient of cisatracurium besylate is -2.12 in a 1-octanol/distilled water system at 25°C. Cisatracurium Besylate Injection, USP is a sterile, non-pyrogenic aqueous solution. Each mL in the single-dose vials contains 10 mg of cisatracurium (equivalent to 13.38 mg of cisatracurium besylate), and benzenesulfonic acid as pH adjuster in water for injection. The pH of cisatracurium besylate is between 3.0 and 3.8.</Description>
</NDC>
<NDC>
<NDCCode>12714-104-20</NDCCode>
<PackageDescription>20 mg in 1 BAG (12714-104-20) </PackageDescription>
<NDC11Code>12714-0104-20</NDC11Code>
<ProductNDC>12714-104</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Tremelimumab</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20221021</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Boehringer Ingelheim Pharma GmbH and Co. KG</LabelerName>
<SubstanceName>TREMELIMUMAB</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/20mg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-05-23</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>21-OCT-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>15343-104-20</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (15343-104-20) * 20 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>15343-0104-20</NDC11Code>
<ProductNDC>15343-104</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Prime Asthma Relief</ProprietaryName>
<NonProprietaryName>Epinephrine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20140821</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>DRNATURALHEALING</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For temporary relief of mild symptoms of intermittent asthma: 1 wheezing, 2 tightness of chest, 3 shortness of breath.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16812-104-09</NDCCode>
<PackageDescription>1 BAG in 1 BAG (16812-104-09) / 20 g in 1 BAG</PackageDescription>
<NDC11Code>16812-0104-09</NDC11Code>
<ProductNDC>16812-104</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Tirzepatide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20241016</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Aurisco Pharmaceutical Co.,Ltd</LabelerName>
<SubstanceName>TIRZEPATIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/20g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-09-13</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>16-OCT-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>24909-104-20</NDCCode>
<PackageDescription>200 g in 1 JAR (24909-104-20) </PackageDescription>
<NDC11Code>24909-0104-20</NDC11Code>
<ProductNDC>24909-104</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Terrasil Tinea Treatment</ProprietaryName>
<ProprietaryNameSuffix>Max</ProprietaryNameSuffix>
<NonProprietaryName>Clotrimazole</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140512</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M005</ApplicationNumber>
<LabelerName>Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions</LabelerName>
<SubstanceName>CLOTRIMAZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Proven clinically effective in the treatment of athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). For effective relief of itching, irritation, redness, scaling, cracking, burning, soreness, and discomfort which can accompany these conditions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>33261-104-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (33261-104-20)</PackageDescription>
<NDC11Code>33261-0104-20</NDC11Code>
<ProductNDC>33261-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidine</ProprietaryName>
<NonProprietaryName>Tizanidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020703</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076286</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Tizanidine tablets are a short-acting drug for the management of spasticity. Because of the short duration of effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Tizanidine hydrochloride USP, is a centrally acting α2-adrenergic agonist. Tizanidine HCl USP (tizanidine) is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiodiazole hydrochloride. Tizanidine’s molecular formula is C9H8ClN5S.HCl, its molecular weight is 290.2 and its structural formula is. Tizanidine tablets USP, is supplied as 2 mg and 4 mg tablets for oral administration. Tizanidine tablets USP, are composed of the active ingredient, tizanidine hydrochloride USP (2.29 mg equivalent to 2 mg tizanidine base and 4.58 mg equivalent to 4 mg tizanidine base), and the inactive ingredients, anhydrous lactose, microcrystalline cellulose, colloidal silicon dioxide and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>43624-043-01</NDCCode>
<PackageDescription>3 TRAY in 1 BOX (43624-043-01) / 104 VIAL in 1 TRAY / 20 mL in 1 VIAL</PackageDescription>
<NDC11Code>43624-0043-01</NDC11Code>
<ProductNDC>43624-043</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Polatuzumab Vedotin Lyophilized Vials 140 Mg</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<StartMarketingDate>20190610</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>BSP Pharmaceuticals S.p.A.</LabelerName>
<SubstanceName>POLATUZUMAB VEDOTIN</SubstanceName>
<StrengthNumber>140</StrengthNumber>
<StrengthUnit>mg/7.52mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-05-11</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>06-OCT-19</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>51079-104-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-104-20) > 1 TABLET in 1 BLISTER PACK (51079-104-01)</PackageDescription>
<NDC11Code>51079-0104-20</NDC11Code>
<ProductNDC>51079-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spironolactone And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Spironolactone And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940411</StartMarketingDate>
<EndMarketingDate>20181130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086513</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>SPIRONOLACTONE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>25; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>51346-104-01</NDCCode>
<PackageDescription>20 mL in 1 CARTON (51346-104-01)</PackageDescription>
<NDC11Code>51346-0104-01</NDC11Code>
<ProductNDC>51346-104</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Essential Solution Caviar Mask Sheet</ProprietaryName>
<NonProprietaryName>Glycerin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>NATURE REPUBLIC CO., LTD.</LabelerName>
<SubstanceName>GLYCERIN</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/20mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-10-25</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51414-104-07</NDCCode>
<PackageDescription>20 g in 1 PACKAGE (51414-104-07) </PackageDescription>
<NDC11Code>51414-0104-07</NDC11Code>
<ProductNDC>51414-104</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Spf30 Sunscreen</ProprietaryName>
<NonProprietaryName>Octinoxate,oxybenzone,octisalate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120912</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Yuyao Jessie Commodity Co.,Ltd.</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; OXYBENZONE</SubstanceName>
<StrengthNumber>7.5; 4; 4</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-02-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>hellps prevent sunburn. if used as directed with other sun protection measures(see Dirctions),decreases the rish of skin cancer and early skin aging carsed by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51414-104-20</NDCCode>
<PackageDescription>160 g in 1 PACKAGE (51414-104-20) </PackageDescription>
<NDC11Code>51414-0104-20</NDC11Code>
<ProductNDC>51414-104</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Spf30 Sunscreen</ProprietaryName>
<NonProprietaryName>Octinoxate,oxybenzone,octisalate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120912</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Yuyao Jessie Commodity Co.,Ltd.</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; OXYBENZONE</SubstanceName>
<StrengthNumber>7.5; 4; 4</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-02-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>hellps prevent sunburn. if used as directed with other sun protection measures(see Dirctions),decreases the rish of skin cancer and early skin aging carsed by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52584-104-20</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 BAG (52584-104-20) > 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>52584-0104-20</NDC11Code>
<ProductNDC>52584-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dopamine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dopamine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20100801</StartMarketingDate>
<EndMarketingDate>20230201</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018132</ApplicationNumber>
<LabelerName>General Injectables & Vaccines, Inc</LabelerName>
<SubstanceName>DOPAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC], Catecholamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100801</StartMarketingDatePackage>
<EndMarketingDatePackage>20230201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54157-104-20</NDCCode>
<PackageDescription>85 g in 1 TUBE (54157-104-20)</PackageDescription>
<NDC11Code>54157-0104-20</NDC11Code>
<ProductNDC>54157-104</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Megafresh</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>GEL, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20140511</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>American Amenities, Inc.</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>.15</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses: Aids in the prevention of dental cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57896-104-20</NDCCode>
<PackageDescription>200 TABLET in 1 BOTTLE (57896-104-20) </PackageDescription>
<NDC11Code>57896-0104-20</NDC11Code>
<ProductNDC>57896-104</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Regular Strength Pain Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Geri-Care Pharmaceutical Corp</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>: 1 temporarily relieves minor aches and pains , 2 temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58159-104-02</NDCCode>
<PackageDescription>20 kg in 1 DRUM (58159-104-02) </PackageDescription>
<NDC11Code>58159-0104-02</NDC11Code>
<ProductNDC>58159-104</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Nicotinamide Riboside Chloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20240821</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>NURAY CHEMICALS PRIVATE LIMITED</LabelerName>
<SubstanceName>NICOTINAMIDE RIBOSIDE CHLORIDE</SubstanceName>
<StrengthNumber>35</StrengthNumber>
<StrengthUnit>kg/35kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-08-30</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>21-AUG-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59316-104-20</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, SPRAY (59316-104-20) </PackageDescription>
<NDC11Code>59316-0104-20</NDC11Code>
<ProductNDC>59316-104</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Biofreeze</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20101101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Reckitt Benckiser LLC</LabelerName>
<SubstanceName>MENTHOL, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporary relief from minor aches and pains of sore muscles and joints associated with: -arthritis - backache - strains - sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61476-104-20</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (61476-104-20) / 200 mL in 1 VIAL, GLASS (61476-104-03) </PackageDescription>
<NDC11Code>61476-0104-20</NDC11Code>
<ProductNDC>61476-104</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Alyglo</ProprietaryName>
<NonProprietaryName>Human Immunoglobulin G</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20231215</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125743</ApplicationNumber>
<LabelerName>GC Biopharma Corp.</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALYGLO (immune globulin intravenous, human-stwk) is a 10% immune globulin liquid for intravenous injection, indicated for the treatment of primary humoral immunodeficiency (PI) in adults. This includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiency (SCID).</IndicationAndUsage>
<Description>ALYGLO (immune globulin intravenous, human-stwk) is a ready-to-use, sterile, liquid preparation of highly purified and concentrated human immunoglobulin G (IgG) antibodies. The product is a clear or slightly opalescent liquid, which is colorless or pale yellow. The distribution of the IgG subclasses is similar to that of normal human plasma. The active ingredient is human immunoglobulin G purified from human Source Plasma and processed using a modified Cohn-Oncley fractionation process, as well as anion and cation exchange chromatography. ALYGLO contains 100 mg/mL protein, of which not less than ≥ 96% is human IgG obtained from human Source Plasma. It is formulated with glycine targeted at 18.8 mg/mL (15.0 – 22.6 mg/mL) as a stabilizer and water for injection as a solvent with pH in the range of 4.5 – 5.5. ALYGLO contains ≤ 20 mcg/mL of IgA. The osmolality is in the range of 240-360 mOsmol/kg, which is similar to physiological osmolality (average 275 to 295 mOsmol/kg). There are no added sugars, sodium or preservatives. All plasma units used in the manufacture of ALYGLO have been tested and approved for manufacture using FDA-licensed serological assays for human hepatitis B surface antigen (HBsAg) and antibodies to human hepatitis C virus (anti-HCV) and human immunodeficiency virus types 1 and 2 (anti-HIV-1/2) as well as FDA-licensed Nucleic Acid Testing (NAT) for HIV-1, HAV, HBV, and HCV and found to be non-reactive (negative). In addition, the plasma has been tested for human parvovirus B19 by NAT. Only plasma that passed virus screening is used for production, and the limit for human parvovirus B19 in the manufacturing plasma pool is set not to exceed 10,000 IU/mL. The manufacturing process for ALYGLO includes three steps to reduce the risk of virus transmission. The steps are “Fractionation I+III, solvent/detergent (S/D) treatment, and Nanofiltration.”. The steps of Fractionation I+III and Nanofiltration (20 nm) remove both enveloped and non-enveloped viruses, and the S/D treatment step inactivates enveloped viruses. The results of virus validation studies for ALYGLO are shown in Table 3, expressed as log10 reduction factor (LRF). NT: Not Tested. 1 Enveloped viruses. 2 Non-enveloped viruses. HIV-1: Human Immunodeficiency virus type 1, a model for HIV-1 and HIV-2, PRV: Pseudorabies virus, a model for large enveloped DNA viruses (e.g., herpes virus); BVDV: Bovine viral diarrhea virus a model for e.g., Hepatitis C virus (HCV) and West Nile virus (WNV); EMCV: Encephalomyocarditis virus, a model for Hepatitis A virus (HAV); PPV: Porcine parvovirus, a model for Human Parvovirus B19.</Description>
</NDC>
<NDC>
<NDCCode>62135-104-20</NDCCode>
<PackageDescription>20 TABLET, CHEWABLE in 1 BOTTLE (62135-104-20) </PackageDescription>
<NDC11Code>62135-0104-20</NDC11Code>
<ProductNDC>62135-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050322</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065205</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>200; 28.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260721</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64220-104-07</NDCCode>
<PackageDescription>20 kg in 1 DRUM (64220-104-07)</PackageDescription>
<NDC11Code>64220-0104-07</NDC11Code>
<ProductNDC>64220-104</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Carvedilol Phosphate Hemihydrate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20080630</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.</LabelerName>
<SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>