{
"NDC": [
{
"NDCCode": "51552-1150-7",
"PackageDescription": "2500 g in 1 CONTAINER (51552-1150-7)",
"NDC11Code": "51552-1150-07",
"ProductNDC": "51552-1150",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Lipobase",
"DosageFormName": "CREAM",
"StartMarketingDate": "20040901",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "PHENOXYETHANOL; EDETATE DISODIUM; POTASSIUM SORBATE",
"StrengthNumber": "1; 1; 1",
"StrengthUnit": "g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "51552-1150-5",
"PackageDescription": "500 g in 1 CONTAINER (51552-1150-5)",
"NDC11Code": "51552-1150-05",
"ProductNDC": "51552-1150",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Lipobase",
"DosageFormName": "CREAM",
"StartMarketingDate": "20040901",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "PHENOXYETHANOL; EDETATE DISODIUM; POTASSIUM SORBATE",
"StrengthNumber": "1; 1; 1",
"StrengthUnit": "g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "62991-1150-7",
"PackageDescription": "25000 g in 1 DRUM (62991-1150-7)",
"NDC11Code": "62991-1150-07",
"ProductNDC": "62991-1150",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sulfadiazine Sodium",
"DosageFormName": "POWDER",
"StartMarketingDate": "20101112",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "LETCO MEDICAL, LLC",
"SubstanceName": "SULFADIAZINE SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "0378-1150-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0378-1150-01) ",
"NDC11Code": "00378-1150-01",
"ProductNDC": "0378-1150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020321",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076008",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20020321",
"EndMarketingDatePackage": "20260531",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1.Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge,” irritability, impatience.",
"Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that are not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C21H31N5O2HCl is represented by the following structural formula. Buspirone hydrochloride tablets are supplied as tablets for oral administration containing 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are provided in a multi-scored tablet design. These tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet). Buspirone hydrochloride tablets contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and sodium starch glycolate (potato)."
},
{
"NDCCode": "0378-1150-05",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (0378-1150-05) ",
"NDC11Code": "00378-1150-05",
"ProductNDC": "0378-1150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020321",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076008",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20020321",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1.Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge,” irritability, impatience.",
"Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that are not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C21H31N5O2HCl is represented by the following structural formula. Buspirone hydrochloride tablets are supplied as tablets for oral administration containing 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are provided in a multi-scored tablet design. These tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet). Buspirone hydrochloride tablets contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and sodium starch glycolate (potato)."
},
{
"NDCCode": "0641-6118-01",
"PackageDescription": "100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6118-01) ",
"NDC11Code": "00641-6118-01",
"ProductNDC": "0641-6118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin And Sulbactam",
"NonProprietaryName": "Ampicillin And Sulbactam",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20091203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065403",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "AMPICILLIN SODIUM; SULBACTAM SODIUM",
"StrengthNumber": "100; 50",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20091203",
"SamplePackage": "N",
"IndicationAndUsage": "Ampicillin and Sulbactam for Injection, USP is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli*, 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, USP is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with Ampicillin and Sulbactam for Injection, USP due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to Ampicillin and Sulbactam for Injection, USP should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to Ampicillin and Sulbactam for Injection, USP. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of Ampicillin and Sulbactam for Injection, USP and other antibacterial drugs, Ampicillin and Sulbactam for Injection, USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Ampicillin and Sulbactam for Injection, USP is a sterile antibacterial fixed-combination drug product 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 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. The pH of the solutions is between 8 and 10. 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. Each 15 g sterile Pharmacy Bulk Package contains ampicillin 10 g and sulbactam 5 g (equivalent to 10.629 g ampicillin sodium and 5.470 g sulbactam sodium). Each sterile Pharmacy Bulk Package contains approximately 1150 mg of sodium. Ampicillin and Sulbactam for Injection, USP Pharmacy Bulk Package is a bottle containing a sterile preparation for parenteral use. The Pharmacy Bulk Package is for use in a pharmacy admixture setting; it provides many single doses of Ampicillin and Sulbactam for Injection, USP for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion. (See DIRECTIONS FOR USE - Directions for Proper Use of Pharmacy Bulk Package section) FURTHER DILUTION IS REQUIRED BEFORE USE."
},
{
"NDCCode": "0641-6121-01",
"PackageDescription": "100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6121-01)",
"NDC11Code": "00641-6121-01",
"ProductNDC": "0641-6121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin And Sulbactam",
"NonProprietaryName": "Ampicillin And Sulbactam",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20091203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065403",
"LabelerName": "West-Ward Pharmaceuticals Corp.",
"SubstanceName": "AMPICILLIN SODIUM; SULBACTAM SODIUM",
"StrengthNumber": "100; 50",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-03-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"IndicationAndUsage": "Ampicillin and Sulbactam for Injection, USP is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli*, 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, USP is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with Ampicillin and Sulbactam for Injection, USP due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to Ampicillin and Sulbactam for Injection, USP should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to Ampicillin and Sulbactam for Injection, USP. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of Ampicillin and Sulbactam for Injection, USP and other antibacterial drugs, Ampicillin and Sulbactam for Injection, USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Ampicillin and Sulbactam for Injection, USP is an injectable antibacterial combination consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C16H18N3NaO4S. The structural formula is. Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C8H10NNaO5S with a molecular weight of 255.22. The structural formula is. Ampicillin and Sulbactam for Injection, USP, ampicillin sodium/sulbactam sodium parenteral combination, is available as a white to off-white dry powder for reconstitution. Ampicillin and Sulbactam for Injection, USP dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL. The pH of the solutions is between 8 and 10. 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. Each sterile Pharmacy Bulk Package contains 15 g Ampicillin and Sulbactam for Injection, USP (equivalent to 10 g ampicillin as the sodium salt plus 5 g sulbactam as the sodium salt). The sodium content is approximately 1150 mg (50 mEq) sodium. Ampicillin and Sulbactam for Injection, USP Pharmacy Bulk Package is a bottle containing a sterile preparation of ampicillin sodium and sulbactam sodium for parenteral use that contains many single doses. The Pharmacy Bulk Package is for use in a pharmacy admixture setting; it provides many single doses of Ampicillin and Sulbactam for Injection, USP for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion. (See DIRECTIONS FOR USE - Directions for Proper Use of Pharmacy Bulk Package.) FURTHER DILUTION IS REQUIRED BEFORE USE."
},
{
"NDCCode": "11344-456-45",
"PackageDescription": "1150 mL in 1 BOTTLE, PUMP (11344-456-45) ",
"NDC11Code": "11344-0456-45",
"ProductNDC": "11344-456",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160610",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Vi-Jon, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2024-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160610",
"SamplePackage": "N",
"IndicationAndUsage": "to decrease bacteria on the skin that could cause disease. recommended for repeated use."
},
{
"NDCCode": "17856-1150-1",
"PackageDescription": "100 POUCH in 1 CASE (17856-1150-1) > 1 CAPSULE in 1 POUCH",
"NDC11Code": "17856-1150-01",
"ProductNDC": "17856-1150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefdinir",
"NonProprietaryName": "Cefdinir",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140207",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065264",
"LabelerName": "Atlantic Biologicals Corps",
"SubstanceName": "CEFDINIR",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir capsules 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. Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.",
"Description": "Cefdinir capsules contain the active ingredient cefdinir, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is [6R-[6α,7β(Z)]]-7-[[(2-amino-4 thiazolyl) (hydroxyimino) acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Cefdinir is a white to slightly brownish-yellow solid. It is slightly soluble in dilute hydrochloric acid and sparingly soluble in 0.1 M pH 7.0 phosphate buffer. The molecular formula is C 14H 13N 5O 5S 2 and the molecular weight is 395.42. Cefdinir has the structural formula shown below:. Cefdinir capsules contain 300 mg of cefdinir and the following inactive ingredients: carboxymethylcellulose calcium; colloidal silicon dioxide; and magnesium stearate. The capsule shells contain D&C Red #28; FD&C Blue #1; FD&C Red #40; gelatin and titanium dioxide."
},
{
"NDCCode": "25021-144-99",
"PackageDescription": "1 BOTTLE in 1 CARTON (25021-144-99) / 100 mL in 1 BOTTLE",
"NDC11Code": "25021-0144-99",
"ProductNDC": "25021-144",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin And Sulbactam",
"NonProprietaryName": "Ampicillin And Sulbactam",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20100812",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065403",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "AMPICILLIN SODIUM; SULBACTAM SODIUM",
"StrengthNumber": "100; 50",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100812",
"SamplePackage": "N",
"IndicationAndUsage": "Ampicillin and Sulbactam for Injection, USP is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli*, 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, USP is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with Ampicillin and Sulbactam for Injection, USP due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to Ampicillin and Sulbactam for Injection, USP should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to Ampicillin and Sulbactam for Injection, USP. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of Ampicillin and Sulbactam for Injection, USP and other antibacterial drugs, Ampicillin and Sulbactam for Injection, USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Ampicillin and Sulbactam for Injection, USP is an injectable antibacterial combination consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C16H18N3NaO4S. The structural formula is:. Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C8H10NNaO5S with a molecular weight of 255.22. The structural formula is:. Ampicillin and Sulbactam for Injection, USP, ampicillin sodium/sulbactam sodium parenteral combination, is available as a white to off-white dry powder for reconstitution. Ampicillin and Sulbactam for Injection, USP dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL. The pH of the solutions is between 8 and 10. 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. Each sterile Pharmacy Bulk Package contains 15 grams Ampicillin and Sulbactam for Injection, USP (equivalent to 10 grams ampicillin as the sodium salt plus 5 grams sulbactam as the sodium salt). The sodium content is approximately 1150 mg (50 mEq) sodium. Ampicillin and Sulbactam for Injection, USP Pharmacy Bulk Package is a bottle containing a sterile preparation of ampicillin sodium and sulbactam sodium for parenteral use that contains many single doses. The Pharmacy Bulk Package is for use in a pharmacy admixture setting; it provides many single doses of Ampicillin and Sulbactam for Injection, USP for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion. (See DIRECTIONS FOR USE - Directions for Proper Use of Pharmacy Bulk Package.) FURTHER DILUTION IS REQUIRED BEFORE USE."
},
{
"NDCCode": "44087-1150-1",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (44087-1150-1) / .5 mL in 1 SYRINGE, GLASS",
"NDC11Code": "44087-1150-01",
"ProductNDC": "44087-1150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ovidrel",
"NonProprietaryName": "Choriogonadotropin Alfa",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20031006",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021149",
"LabelerName": "EMD Serono, Inc.",
"SubstanceName": "CHORIOGONADOTROPIN ALFA",
"StrengthNumber": "250",
"StrengthUnit": "ug/.5mL",
"Pharm_Classes": "Gonadotropin [EPC], Gonadotropins [CS]",
"Status": "Active",
"LastUpdate": "2023-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20031006",
"SamplePackage": "N",
"IndicationAndUsage": "Ovidrel® PreFilled Syringe (choriogonadotropin alfa injection) is indicated for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulating hormones as part of an Assisted Reproductive Technology (ART) program such as in vitro fertilization and embryo transfer. Ovidrel® PreFilled Syringe is also indicated for the induction of ovulation (OI) and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure.",
"Description": "Ovidrel® PreFilled Syringe (choriogonadotropin alfa injection) is a sterile liquid preparation of choriogonadotropin alfa (recombinant human Chorionic Gonadotropin, r-hCG). Choriogonadotropin alfa is a water soluble glycoprotein consisting of two non-covalently linked subunits - designated α and β - consisting of 92 and 145 amino acid residues, respectively, with carbohydrate moieties linked to ASN-52 and ASN-78 (on alpha subunit) and ASN-13, ASN-30, SER-121, SER-127, SER-132 and SER-138 (on beta subunit). The primary structure of the α - chain of r-hCG is identical to that of the α - chain of hCG, FSH and LH. The glycoform pattern of the α - subunit of r-hCG is closely comparable to urinary derived hCG (u-hCG), the differences mainly being due to the branching and sialylation extent of the oligosaccharides. The β - chain has both O- and N-glycosylation sites and its structure and glycosylation pattern are also very similar to that of u-hCG. The production process involves expansion of genetically modified Chinese Hamster Ovary (CHO) cells from an extensively characterized cell bank into large scale cell culture processing. Choriogonadotropin alfa is secreted by the CHO cells directly into the cell culture medium that is then purified using a series of chromatographic steps. This process yields a product with a high level of purity and consistent product characteristics including glycoforms and biological activity. The biological activity of choriogonadotropin alfa is determined using the seminal vesicle weight gain test in male rats described in the \"Chorionic Gonadotrophins\" monograph of the European Pharmacopoeia. The in vivo biological activity of choriogonadotropin alfa has been calibrated against the third international reference preparation IS75/587 for chorionic gonadotropin. Ovidrel® PreFilled Syringe is a sterile, liquid intended for subcutaneous (SC) injection. Each Ovidrel® PreFilled Syringe is filled with 0.515 mL containing 257.5 µg of choriogonadotropin alfa, 28.1 mg mannitol, 505 µg 85% O-phosphoric acid, 103 µg L-methionine, 51.5 µg Poloxamer 188, Sodium Hydroxide (for pH adjustment), and Water for Injection to deliver 250 µg of choriogonadotropin alfa in 0.5 mL. The pH of the solution is 6.5 to 7.5. Therapeutic Class: Infertility."
},
{
"NDCCode": "48951-1150-6",
"PackageDescription": "125 mL in 1 BOTTLE, GLASS (48951-1150-6) ",
"NDC11Code": "48951-1150-06",
"ProductNDC": "48951-1150",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arinica Nettle Essence",
"NonProprietaryName": "Arnica Nettle Essence",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc",
"SubstanceName": "URTICA URENS; ARNICA MONTANA FLOWER; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; THUJA OCCIDENTALIS WHOLE; LYTTA VESICATORIA; SILVER",
"StrengthNumber": "1; 1; 1; 1; 1; 7; 7",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N"
},
{
"NDCCode": "52796-171-50",
"PackageDescription": "50 mL in 1 CONTAINER (52796-171-50) ",
"NDC11Code": "52796-0171-50",
"ProductNDC": "52796-171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Floriva Plus",
"NonProprietaryName": "Vitamin A Acetate, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Thiamine Hydrochloride, Riboflavin 5-phosphate Sodium, Niacinamide, Pyridoxine Hydrochloride, Levomefolate Glucosamine, Cyanocobalamin, Biotin, Pantothenic Acid, And Sodium Fluoride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20160620",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "BonGeo Pharmaceuticals, Inc.",
"SubstanceName": "VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE GLUCOSAMINE; CYANOCOBALAMIN; BIOTIN; PANTOTHENIC ACID; SODIUM FLUORIDE",
"StrengthNumber": "1150; 32; 400; 5; .5; .6; 2; .4; 29.7; 2; 3; 1; .25",
"StrengthUnit": "[iU]/mL; mg/mL; [iU]/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL; ug/mL; ug/mL; mg/mL; mg/mL",
"Pharm_Classes": "Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin A [CS],Vitamin A [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20160620",
"SamplePackage": "N"
},
{
"NDCCode": "55150-118-01",
"PackageDescription": "1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE",
"NDC11Code": "55150-0118-01",
"ProductNDC": "55150-118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin And Sulbactam",
"NonProprietaryName": "Ampicillin Sodium And Sulbactam Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090339",
"LabelerName": "Eugia US LLC",
"SubstanceName": "AMPICILLIN SODIUM; SULBACTAM SODIUM",
"StrengthNumber": "100; 50",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120210",
"SamplePackage": "N",
"IndicationAndUsage": "Ampicillin and sulbactam for injection, USP is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli,*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, USP is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with ampicillin and sulbactam for injection, USP due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to ampicillin and sulbactam for injection, USP should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to ampicillin and sulbactam for injection, USP. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of ampicillin and sulbactam for injection, USP and other antibacterial drugs, ampicillin and sulbactam for injection, USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Ampicillin and sulbactam for injection, USP is an injectable antibacterial combination consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. HOWEVER, THE INTENT OF THE PHARMACY BULK PACKAGE IS FOR PREPARATION OF SOLUTIONS FOR IV INFUSION ONLY. 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 parenteral combination, is available as a white to off-white, crystalline powder for reconstitution. Ampicillin and sulbactam for injection crystalline 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 and 10. 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. Each sterile Pharmacy Bulk Package contains 15 g ampicillin and sulbactam for injection (10 g ampicillin as the sodium salt plus 5 g sulbactam as the sodium salt) and approximately 1150 mg (50 mEq) sodium. Ampicillin and sulbactam for injection Pharmacy Bulk Package is a bottle containing a sterile preparation of ampicillin sodium and sulbactam sodium for parenteral use that contains many single doses. The Pharmacy Bulk Package is for use in a pharmacy admixture setting; it provides many single doses of ampicillin and sulbactam for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion (see DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE). FURTHER DILUTION IS REQUIRED BEFORE USE."
},
{
"NDCCode": "55150-118-99",
"PackageDescription": "1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-99) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE",
"NDC11Code": "55150-0118-99",
"ProductNDC": "55150-118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin And Sulbactam",
"NonProprietaryName": "Ampicillin Sodium And Sulbactam Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090339",
"LabelerName": "Eugia US LLC",
"SubstanceName": "AMPICILLIN SODIUM; SULBACTAM SODIUM",
"StrengthNumber": "100; 50",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120210",
"SamplePackage": "N",
"IndicationAndUsage": "Ampicillin and sulbactam for injection, USP is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli,*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, USP is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with ampicillin and sulbactam for injection, USP due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to ampicillin and sulbactam for injection, USP should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to ampicillin and sulbactam for injection, USP. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of ampicillin and sulbactam for injection, USP and other antibacterial drugs, ampicillin and sulbactam for injection, USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Ampicillin and sulbactam for injection, USP is an injectable antibacterial combination consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. HOWEVER, THE INTENT OF THE PHARMACY BULK PACKAGE IS FOR PREPARATION OF SOLUTIONS FOR IV INFUSION ONLY. 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 parenteral combination, is available as a white to off-white, crystalline powder for reconstitution. Ampicillin and sulbactam for injection crystalline 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 and 10. 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. Each sterile Pharmacy Bulk Package contains 15 g ampicillin and sulbactam for injection (10 g ampicillin as the sodium salt plus 5 g sulbactam as the sodium salt) and approximately 1150 mg (50 mEq) sodium. Ampicillin and sulbactam for injection Pharmacy Bulk Package is a bottle containing a sterile preparation of ampicillin sodium and sulbactam sodium for parenteral use that contains many single doses. The Pharmacy Bulk Package is for use in a pharmacy admixture setting; it provides many single doses of ampicillin and sulbactam for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion (see DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE). FURTHER DILUTION IS REQUIRED BEFORE USE."
},
{
"NDCCode": "71288-033-75",
"PackageDescription": "1 BOTTLE in 1 CARTON (71288-033-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE",
"NDC11Code": "71288-0033-75",
"ProductNDC": "71288-033",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin And Sulbactam",
"NonProprietaryName": "Ampicillin Sodium And Sulbactam Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20061127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065403",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "AMPICILLIN SODIUM; SULBACTAM SODIUM",
"StrengthNumber": "10; 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": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20061127",
"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.",
"Description": "Ampicillin and Sulbactam for Injection, USP is a sterile antibacterial fixed-combination drug product 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 issodium 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 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. The pH of the solutions is between 8 and 10. 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. Each 15 g sterile Pharmacy Bulk Package contains ampicillin 10 g and sulbactam 5 g (equivalent to 10.629 g ampicillin sodium and 5.470 g sulbactam sodium). Each sterile Pharmacy Bulk Package contains approximately 1150 mg of sodium. Ampicillin and Sulbactam for Injection, USP Pharmacy Bulk Package is a bottle containing a sterile preparation for parenteral use. The Pharmacy Bulk Package is for use in a pharmacy admixture setting; it provides many single doses of Ampicillin and Sulbactam for Injection, USP for additionto suitable parenteral fluids in the preparation of admixtures for intravenous infusion. (See DIRECTIONS FOR USE - Directions for Proper Use of Pharmacy Bulk Package section). FURTHER DILUTION IS REQUIRED BEFORE USE."
},
{
"NDCCode": "71335-1150-1",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1150-1) ",
"NDC11Code": "71335-1150-01",
"ProductNDC": "71335-1150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desvenlafaxine Succinate",
"NonProprietaryName": "Desvenlafaxine Succinate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204172",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DESVENLAFAXINE SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190828",
"SamplePackage": "N",
"IndicationAndUsage": "Desvenlafaxine extended-release tablet is indicated for the treatment of adults with major depressive disorder (MDD) [see CLINICAL STUDIES (14)].",
"Description": "Desvenlafaxine is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine. (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C16H25NO2 (free base) and C16H25NO2C4H6O4H2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate monohydrate is a white to creamish crystalline powder that is soluble in water. The solubility of desvenlafaxine succinate monohydrate is pH dependent. Its octanol: aqueous system (at pH 7.0) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each film-coated tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate monohydrate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 25 mg tablet consist of colloidal silicon dioxide, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 50 mg tablet consist of colloidal silicon dioxide, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 100 mg tablet consist of colloidal silicon dioxide, FD&C yellow #6 aluminum lake, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide."
},
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"LabelerName": "Bryant Ranch Prepack",
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"IndicationAndUsage": "Desvenlafaxine extended-release tablet is indicated for the treatment of adults with major depressive disorder (MDD) [see CLINICAL STUDIES (14)].",
"Description": "Desvenlafaxine is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine. (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C16H25NO2 (free base) and C16H25NO2C4H6O4H2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate monohydrate is a white to creamish crystalline powder that is soluble in water. The solubility of desvenlafaxine succinate monohydrate is pH dependent. Its octanol: aqueous system (at pH 7.0) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each film-coated tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate monohydrate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 25 mg tablet consist of colloidal silicon dioxide, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 50 mg tablet consist of colloidal silicon dioxide, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 100 mg tablet consist of colloidal silicon dioxide, FD&C yellow #6 aluminum lake, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide."
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"IndicationAndUsage": "Desvenlafaxine extended-release tablet is indicated for the treatment of adults with major depressive disorder (MDD) [see CLINICAL STUDIES (14)].",
"Description": "Desvenlafaxine is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine. (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C16H25NO2 (free base) and C16H25NO2C4H6O4H2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate monohydrate is a white to creamish crystalline powder that is soluble in water. The solubility of desvenlafaxine succinate monohydrate is pH dependent. Its octanol: aqueous system (at pH 7.0) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each film-coated tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate monohydrate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 25 mg tablet consist of colloidal silicon dioxide, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 50 mg tablet consist of colloidal silicon dioxide, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 100 mg tablet consist of colloidal silicon dioxide, FD&C yellow #6 aluminum lake, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide."
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{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Bryant Ranch Prepack",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
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"SamplePackage": "N",
"IndicationAndUsage": "Desvenlafaxine extended-release tablet is indicated for the treatment of adults with major depressive disorder (MDD) [see CLINICAL STUDIES (14)].",
"Description": "Desvenlafaxine is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine. (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C16H25NO2 (free base) and C16H25NO2C4H6O4H2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate monohydrate is a white to creamish crystalline powder that is soluble in water. The solubility of desvenlafaxine succinate monohydrate is pH dependent. Its octanol: aqueous system (at pH 7.0) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each film-coated tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate monohydrate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 25 mg tablet consist of colloidal silicon dioxide, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 50 mg tablet consist of colloidal silicon dioxide, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 100 mg tablet consist of colloidal silicon dioxide, FD&C yellow #6 aluminum lake, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide."
},
{
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"ProductNDC": "71335-1150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DESVENLAFAXINE SUCCINATE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
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"IndicationAndUsage": "Desvenlafaxine extended-release tablet is indicated for the treatment of adults with major depressive disorder (MDD) [see CLINICAL STUDIES (14)].",
"Description": "Desvenlafaxine is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine. (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C16H25NO2 (free base) and C16H25NO2C4H6O4H2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate monohydrate is a white to creamish crystalline powder that is soluble in water. The solubility of desvenlafaxine succinate monohydrate is pH dependent. Its octanol: aqueous system (at pH 7.0) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each film-coated tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate monohydrate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 25 mg tablet consist of colloidal silicon dioxide, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 50 mg tablet consist of colloidal silicon dioxide, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 100 mg tablet consist of colloidal silicon dioxide, FD&C yellow #6 aluminum lake, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide."
},
{
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"PackageDescription": "10 BOTTLE in 1 CARTON (72603-444-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE",
"NDC11Code": "72603-0444-01",
"ProductNDC": "72603-444",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin And Sulbactam",
"NonProprietaryName": "Ampicillin Sodium And Sulbactam Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
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"MarketingCategoryName": "ANDA",
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"LabelerName": "NorthStar Rx, LLC",
"SubstanceName": "AMPICILLIN SODIUM; SULBACTAM SODIUM",
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"StrengthUnit": "g/1; g/1",
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"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. THE INTENT OF THIS PHARMACY BULK PACKAGE IS FOR PREPARATION OF SOLUTIONS FOR IV INFUSION ONLY. 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. Each sterile Pharmacy Bulk Package contains 15 grams Ampicillin and Sulbactam for Injection (equivalent to 10 g ampicillin as the sodium salt plus 5 g sulbactam as the sodium salt). The sodium content per vial is 1150 mg (50 mEq) sodium. Ampicillin and Sulbactam for Injection Pharmacy Bulk Package is a vial containing a sterile preparation of ampicillin sodium and sulbactam sodium for parenteral use that contains many single doses. The Pharmacy Bulk Package is for use in a pharmacy admixture setting; it provides many single doses of ampicillin and sulbactam for injection for addition to suitable parenteral fluids in the preparation and administration for intravenous infusion (see DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE section). FURTHER DILUTION IS REQUIRED BEFORE USE."
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"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. THE INTENT OF THIS PHARMACY BULK PACKAGE IS FOR PREPARATION OF SOLUTIONS FOR IV INFUSION ONLY. 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. Each sterile Pharmacy Bulk Package contains 15 grams Ampicillin and Sulbactam for Injection (equivalent to 10 g ampicillin as the sodium salt plus 5 g sulbactam as the sodium salt). The sodium content per vial is 1150 mg (50 mEq) sodium. Ampicillin and Sulbactam for Injection Pharmacy Bulk Package is a vial containing a sterile preparation of ampicillin sodium and sulbactam sodium for parenteral use that contains many single doses. The Pharmacy Bulk Package is for use in a pharmacy admixture setting; it provides many single doses of ampicillin and sulbactam for injection for addition to suitable parenteral fluids in the preparation and administration for intravenous infusion (see DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE section). FURTHER DILUTION IS REQUIRED BEFORE USE."
},
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
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"MarketingCategoryName": "ANDA",
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"LabelerName": "H. J. Harkins Company Inc.",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]",
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"StartMarketingDatePackage": "20170216",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Epilepsy. Adjunctive Therapy. Lamotrigine tablets, USP is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older:. Monotherapy. Lamotrigine tablets, USP is indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED). Safety and effectiveness of lamotrigine tablets, USP have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs. 1.2 Bipolar Disorder. Lamotrigine tablets, USP is indicated for the maintenance treatment of Bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy [SEE CLINICAL STUDIES (14.1)]. Limitations of Use. Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine tablets, USP in the acute treatment of mood episodes has not been established.",
"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3, 5-diamino-6-(2, 3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKaof 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine Tablets, USP are supplied for oral administration as 25 mg (light pink), 100 mg (light pink), 150 mg (light pink), and 200 mg (light pink) tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, povidone, sodium starch glycolate, black iron oxide, iron oxide red and yellow iron oxide. Meets USP Dissolution Test 3."
},
{
"NDCCode": "51552-0004-7",
"PackageDescription": "2500 g in 1 CONTAINER (51552-0004-7)",
"NDC11Code": "51552-0004-07",
"ProductNDC": "51552-0004",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Polyethylene Glycol 8000",
"DosageFormName": "GRANULE",
"StartMarketingDate": "20040901",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "POLYETHYLENE GLYCOL 8000",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "51552-0006-7",
"PackageDescription": "1000 g in 1 CONTAINER (51552-0006-7) ",
"NDC11Code": "51552-0006-07",
"ProductNDC": "51552-0006",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Progesterone",
"DosageFormName": "POWDER",
"StartMarketingDate": "19980401",
"EndMarketingDate": "20261219",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "PROGESTERONE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"StartMarketingDatePackage": "01-APR-98",
"EndMarketingDatePackage": "24-JUL-24"
},
{
"NDCCode": "51552-0007-7",
"PackageDescription": "2500 g in 1 CONTAINER (51552-0007-7) ",
"NDC11Code": "51552-0007-07",
"ProductNDC": "51552-0007",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Fatty Acid",
"DosageFormName": "PELLET",
"StartMarketingDate": "19980401",
"EndMarketingDate": "20240523",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "PALM KERNEL OIL",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"StartMarketingDatePackage": "01-APR-98",
"EndMarketingDatePackage": "23-MAY-24"
},
{
"NDCCode": "51552-0008-7",
"PackageDescription": "2500 g in 1 CONTAINER (51552-0008-7) ",
"NDC11Code": "51552-0008-07",
"ProductNDC": "51552-0008",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Peg Blend",
"DosageFormName": "CREAM",
"StartMarketingDate": "19980401",
"EndMarketingDate": "20260509",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "POLYETHYLENE GLYCOL 400; POLYETHYLENE GLYCOL 8000; POLYSORBATE 80",
"StrengthNumber": "1; 1; 1",
"StrengthUnit": "g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"StartMarketingDatePackage": "01-APR-98",
"EndMarketingDatePackage": "16-APR-26"
},
{
"NDCCode": "51552-0018-7",
"PackageDescription": "2500 g in 1 CONTAINER (51552-0018-7)",
"NDC11Code": "51552-0018-07",
"ProductNDC": "51552-0018",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20040901",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "51552-0020-7",
"PackageDescription": "1000 g in 1 CONTAINER (51552-0020-7) ",
"NDC11Code": "51552-0020-07",
"ProductNDC": "51552-0020",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20040901",
"EndMarketingDate": "20250613",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"StartMarketingDatePackage": "01-SEP-04",
"EndMarketingDatePackage": "13-JUN-25"
}
]
}
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<NDCList>
<NDC>
<NDCCode>51552-1150-7</NDCCode>
<PackageDescription>2500 g in 1 CONTAINER (51552-1150-7)</PackageDescription>
<NDC11Code>51552-1150-07</NDC11Code>
<ProductNDC>51552-1150</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Lipobase</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<StartMarketingDate>20040901</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>PHENOXYETHANOL; EDETATE DISODIUM; POTASSIUM SORBATE</SubstanceName>
<StrengthNumber>1; 1; 1</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51552-1150-5</NDCCode>
<PackageDescription>500 g in 1 CONTAINER (51552-1150-5)</PackageDescription>
<NDC11Code>51552-1150-05</NDC11Code>
<ProductNDC>51552-1150</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Lipobase</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<StartMarketingDate>20040901</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>PHENOXYETHANOL; EDETATE DISODIUM; POTASSIUM SORBATE</SubstanceName>
<StrengthNumber>1; 1; 1</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>62991-1150-7</NDCCode>
<PackageDescription>25000 g in 1 DRUM (62991-1150-7)</PackageDescription>
<NDC11Code>62991-1150-07</NDC11Code>
<ProductNDC>62991-1150</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Sulfadiazine Sodium</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20101112</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>LETCO MEDICAL, LLC</LabelerName>
<SubstanceName>SULFADIAZINE SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0378-1150-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0378-1150-01) </PackageDescription>
<NDC11Code>00378-1150-01</NDC11Code>
<ProductNDC>0378-1150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020321</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076008</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020321</StartMarketingDatePackage>
<EndMarketingDatePackage>20260531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1.Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge,” irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that are not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C21H31N5O2HCl is represented by the following structural formula. Buspirone hydrochloride tablets are supplied as tablets for oral administration containing 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are provided in a multi-scored tablet design. These tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet). Buspirone hydrochloride tablets contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and sodium starch glycolate (potato).</Description>
</NDC>
<NDC>
<NDCCode>0378-1150-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (0378-1150-05) </PackageDescription>
<NDC11Code>00378-1150-05</NDC11Code>
<ProductNDC>0378-1150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020321</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076008</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020321</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1.Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge,” irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that are not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C21H31N5O2HCl is represented by the following structural formula. Buspirone hydrochloride tablets are supplied as tablets for oral administration containing 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are provided in a multi-scored tablet design. These tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet). Buspirone hydrochloride tablets contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and sodium starch glycolate (potato).</Description>
</NDC>
<NDC>
<NDCCode>0641-6118-01</NDCCode>
<PackageDescription>100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6118-01) </PackageDescription>
<NDC11Code>00641-6118-01</NDC11Code>
<ProductNDC>0641-6118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin And Sulbactam</ProprietaryName>
<NonProprietaryName>Ampicillin And Sulbactam</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065403</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>AMPICILLIN SODIUM; SULBACTAM SODIUM</SubstanceName>
<StrengthNumber>100; 50</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ampicillin and Sulbactam for Injection, USP is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli*, 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, USP is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with Ampicillin and Sulbactam for Injection, USP due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to Ampicillin and Sulbactam for Injection, USP should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to Ampicillin and Sulbactam for Injection, USP. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of Ampicillin and Sulbactam for Injection, USP and other antibacterial drugs, Ampicillin and Sulbactam for Injection, USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Ampicillin and Sulbactam for Injection, USP is a sterile antibacterial fixed-combination drug product 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 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. The pH of the solutions is between 8 and 10. 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. Each 15 g sterile Pharmacy Bulk Package contains ampicillin 10 g and sulbactam 5 g (equivalent to 10.629 g ampicillin sodium and 5.470 g sulbactam sodium). Each sterile Pharmacy Bulk Package contains approximately 1150 mg of sodium. Ampicillin and Sulbactam for Injection, USP Pharmacy Bulk Package is a bottle containing a sterile preparation for parenteral use. The Pharmacy Bulk Package is for use in a pharmacy admixture setting; it provides many single doses of Ampicillin and Sulbactam for Injection, USP for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion. (See DIRECTIONS FOR USE - Directions for Proper Use of Pharmacy Bulk Package section) FURTHER DILUTION IS REQUIRED BEFORE USE.</Description>
</NDC>
<NDC>
<NDCCode>0641-6121-01</NDCCode>
<PackageDescription>100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6121-01)</PackageDescription>
<NDC11Code>00641-6121-01</NDC11Code>
<ProductNDC>0641-6121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin And Sulbactam</ProprietaryName>
<NonProprietaryName>Ampicillin And Sulbactam</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065403</ApplicationNumber>
<LabelerName>West-Ward Pharmaceuticals Corp.</LabelerName>
<SubstanceName>AMPICILLIN SODIUM; SULBACTAM SODIUM</SubstanceName>
<StrengthNumber>100; 50</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-03-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ampicillin and Sulbactam for Injection, USP is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli*, 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, USP is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with Ampicillin and Sulbactam for Injection, USP due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to Ampicillin and Sulbactam for Injection, USP should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to Ampicillin and Sulbactam for Injection, USP. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of Ampicillin and Sulbactam for Injection, USP and other antibacterial drugs, Ampicillin and Sulbactam for Injection, USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Ampicillin and Sulbactam for Injection, USP is an injectable antibacterial combination consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C16H18N3NaO4S. The structural formula is. Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C8H10NNaO5S with a molecular weight of 255.22. The structural formula is. Ampicillin and Sulbactam for Injection, USP, ampicillin sodium/sulbactam sodium parenteral combination, is available as a white to off-white dry powder for reconstitution. Ampicillin and Sulbactam for Injection, USP dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL. The pH of the solutions is between 8 and 10. 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. Each sterile Pharmacy Bulk Package contains 15 g Ampicillin and Sulbactam for Injection, USP (equivalent to 10 g ampicillin as the sodium salt plus 5 g sulbactam as the sodium salt). The sodium content is approximately 1150 mg (50 mEq) sodium. Ampicillin and Sulbactam for Injection, USP Pharmacy Bulk Package is a bottle containing a sterile preparation of ampicillin sodium and sulbactam sodium for parenteral use that contains many single doses. The Pharmacy Bulk Package is for use in a pharmacy admixture setting; it provides many single doses of Ampicillin and Sulbactam for Injection, USP for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion. (See DIRECTIONS FOR USE - Directions for Proper Use of Pharmacy Bulk Package.) FURTHER DILUTION IS REQUIRED BEFORE USE.</Description>
</NDC>
<NDC>
<NDCCode>11344-456-45</NDCCode>
<PackageDescription>1150 mL in 1 BOTTLE, PUMP (11344-456-45) </PackageDescription>
<NDC11Code>11344-0456-45</NDC11Code>
<ProductNDC>11344-456</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160610</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Vi-Jon, LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to decrease bacteria on the skin that could cause disease. recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17856-1150-1</NDCCode>
<PackageDescription>100 POUCH in 1 CASE (17856-1150-1) > 1 CAPSULE in 1 POUCH</PackageDescription>
<NDC11Code>17856-1150-01</NDC11Code>
<ProductNDC>17856-1150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefdinir</ProprietaryName>
<NonProprietaryName>Cefdinir</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140207</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065264</ApplicationNumber>
<LabelerName>Atlantic Biologicals Corps</LabelerName>
<SubstanceName>CEFDINIR</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir capsules 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. Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.</IndicationAndUsage>
<Description>Cefdinir capsules contain the active ingredient cefdinir, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is [6R-[6α,7β(Z)]]-7-[[(2-amino-4 thiazolyl) (hydroxyimino) acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Cefdinir is a white to slightly brownish-yellow solid. It is slightly soluble in dilute hydrochloric acid and sparingly soluble in 0.1 M pH 7.0 phosphate buffer. The molecular formula is C 14H 13N 5O 5S 2 and the molecular weight is 395.42. Cefdinir has the structural formula shown below:. Cefdinir capsules contain 300 mg of cefdinir and the following inactive ingredients: carboxymethylcellulose calcium; colloidal silicon dioxide; and magnesium stearate. The capsule shells contain D&C Red #28; FD&C Blue #1; FD&C Red #40; gelatin and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>25021-144-99</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (25021-144-99) / 100 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>25021-0144-99</NDC11Code>
<ProductNDC>25021-144</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin And Sulbactam</ProprietaryName>
<NonProprietaryName>Ampicillin And Sulbactam</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20100812</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065403</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>AMPICILLIN SODIUM; SULBACTAM SODIUM</SubstanceName>
<StrengthNumber>100; 50</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100812</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ampicillin and Sulbactam for Injection, USP is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli*, 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, USP is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with Ampicillin and Sulbactam for Injection, USP due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to Ampicillin and Sulbactam for Injection, USP should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to Ampicillin and Sulbactam for Injection, USP. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of Ampicillin and Sulbactam for Injection, USP and other antibacterial drugs, Ampicillin and Sulbactam for Injection, USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Ampicillin and Sulbactam for Injection, USP is an injectable antibacterial combination consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C16H18N3NaO4S. The structural formula is:. Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C8H10NNaO5S with a molecular weight of 255.22. The structural formula is:. Ampicillin and Sulbactam for Injection, USP, ampicillin sodium/sulbactam sodium parenteral combination, is available as a white to off-white dry powder for reconstitution. Ampicillin and Sulbactam for Injection, USP dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL. The pH of the solutions is between 8 and 10. 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. Each sterile Pharmacy Bulk Package contains 15 grams Ampicillin and Sulbactam for Injection, USP (equivalent to 10 grams ampicillin as the sodium salt plus 5 grams sulbactam as the sodium salt). The sodium content is approximately 1150 mg (50 mEq) sodium. Ampicillin and Sulbactam for Injection, USP Pharmacy Bulk Package is a bottle containing a sterile preparation of ampicillin sodium and sulbactam sodium for parenteral use that contains many single doses. The Pharmacy Bulk Package is for use in a pharmacy admixture setting; it provides many single doses of Ampicillin and Sulbactam for Injection, USP for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion. (See DIRECTIONS FOR USE - Directions for Proper Use of Pharmacy Bulk Package.) FURTHER DILUTION IS REQUIRED BEFORE USE.</Description>
</NDC>
<NDC>
<NDCCode>44087-1150-1</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (44087-1150-1) / .5 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>44087-1150-01</NDC11Code>
<ProductNDC>44087-1150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ovidrel</ProprietaryName>
<NonProprietaryName>Choriogonadotropin Alfa</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20031006</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021149</ApplicationNumber>
<LabelerName>EMD Serono, Inc.</LabelerName>
<SubstanceName>CHORIOGONADOTROPIN ALFA</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/.5mL</StrengthUnit>
<Pharm_Classes>Gonadotropin [EPC], Gonadotropins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20031006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ovidrel® PreFilled Syringe (choriogonadotropin alfa injection) is indicated for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulating hormones as part of an Assisted Reproductive Technology (ART) program such as in vitro fertilization and embryo transfer. Ovidrel® PreFilled Syringe is also indicated for the induction of ovulation (OI) and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure.</IndicationAndUsage>
<Description>Ovidrel® PreFilled Syringe (choriogonadotropin alfa injection) is a sterile liquid preparation of choriogonadotropin alfa (recombinant human Chorionic Gonadotropin, r-hCG). Choriogonadotropin alfa is a water soluble glycoprotein consisting of two non-covalently linked subunits - designated α and β - consisting of 92 and 145 amino acid residues, respectively, with carbohydrate moieties linked to ASN-52 and ASN-78 (on alpha subunit) and ASN-13, ASN-30, SER-121, SER-127, SER-132 and SER-138 (on beta subunit). The primary structure of the α - chain of r-hCG is identical to that of the α - chain of hCG, FSH and LH. The glycoform pattern of the α - subunit of r-hCG is closely comparable to urinary derived hCG (u-hCG), the differences mainly being due to the branching and sialylation extent of the oligosaccharides. The β - chain has both O- and N-glycosylation sites and its structure and glycosylation pattern are also very similar to that of u-hCG. The production process involves expansion of genetically modified Chinese Hamster Ovary (CHO) cells from an extensively characterized cell bank into large scale cell culture processing. Choriogonadotropin alfa is secreted by the CHO cells directly into the cell culture medium that is then purified using a series of chromatographic steps. This process yields a product with a high level of purity and consistent product characteristics including glycoforms and biological activity. The biological activity of choriogonadotropin alfa is determined using the seminal vesicle weight gain test in male rats described in the "Chorionic Gonadotrophins" monograph of the European Pharmacopoeia. The in vivo biological activity of choriogonadotropin alfa has been calibrated against the third international reference preparation IS75/587 for chorionic gonadotropin. Ovidrel® PreFilled Syringe is a sterile, liquid intended for subcutaneous (SC) injection. Each Ovidrel® PreFilled Syringe is filled with 0.515 mL containing 257.5 µg of choriogonadotropin alfa, 28.1 mg mannitol, 505 µg 85% O-phosphoric acid, 103 µg L-methionine, 51.5 µg Poloxamer 188, Sodium Hydroxide (for pH adjustment), and Water for Injection to deliver 250 µg of choriogonadotropin alfa in 0.5 mL. The pH of the solution is 6.5 to 7.5. Therapeutic Class: Infertility.</Description>
</NDC>
<NDC>
<NDCCode>48951-1150-6</NDCCode>
<PackageDescription>125 mL in 1 BOTTLE, GLASS (48951-1150-6) </PackageDescription>
<NDC11Code>48951-1150-06</NDC11Code>
<ProductNDC>48951-1150</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arinica Nettle Essence</ProprietaryName>
<NonProprietaryName>Arnica Nettle Essence</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc</LabelerName>
<SubstanceName>URTICA URENS; ARNICA MONTANA FLOWER; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; THUJA OCCIDENTALIS WHOLE; LYTTA VESICATORIA; SILVER</SubstanceName>
<StrengthNumber>1; 1; 1; 1; 1; 7; 7</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52796-171-50</NDCCode>
<PackageDescription>50 mL in 1 CONTAINER (52796-171-50) </PackageDescription>
<NDC11Code>52796-0171-50</NDC11Code>
<ProductNDC>52796-171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Floriva Plus</ProprietaryName>
<NonProprietaryName>Vitamin A Acetate, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Thiamine Hydrochloride, Riboflavin 5-phosphate Sodium, Niacinamide, Pyridoxine Hydrochloride, Levomefolate Glucosamine, Cyanocobalamin, Biotin, Pantothenic Acid, And Sodium Fluoride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160620</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>BonGeo Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE GLUCOSAMINE; CYANOCOBALAMIN; BIOTIN; PANTOTHENIC ACID; SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1150; 32; 400; 5; .5; .6; 2; .4; 29.7; 2; 3; 1; .25</StrengthNumber>
<StrengthUnit>[iU]/mL; mg/mL; [iU]/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL; ug/mL; ug/mL; mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin A [CS],Vitamin A [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55150-118-01</NDCCode>
<PackageDescription>1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE</PackageDescription>
<NDC11Code>55150-0118-01</NDC11Code>
<ProductNDC>55150-118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin And Sulbactam</ProprietaryName>
<NonProprietaryName>Ampicillin Sodium And Sulbactam Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090339</ApplicationNumber>
<LabelerName>Eugia US LLC</LabelerName>
<SubstanceName>AMPICILLIN SODIUM; SULBACTAM SODIUM</SubstanceName>
<StrengthNumber>100; 50</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ampicillin and sulbactam for injection, USP is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli,*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, USP is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with ampicillin and sulbactam for injection, USP due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to ampicillin and sulbactam for injection, USP should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to ampicillin and sulbactam for injection, USP. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of ampicillin and sulbactam for injection, USP and other antibacterial drugs, ampicillin and sulbactam for injection, USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Ampicillin and sulbactam for injection, USP is an injectable antibacterial combination consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. HOWEVER, THE INTENT OF THE PHARMACY BULK PACKAGE IS FOR PREPARATION OF SOLUTIONS FOR IV INFUSION ONLY. 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 parenteral combination, is available as a white to off-white, crystalline powder for reconstitution. Ampicillin and sulbactam for injection crystalline 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 and 10. 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. Each sterile Pharmacy Bulk Package contains 15 g ampicillin and sulbactam for injection (10 g ampicillin as the sodium salt plus 5 g sulbactam as the sodium salt) and approximately 1150 mg (50 mEq) sodium. Ampicillin and sulbactam for injection Pharmacy Bulk Package is a bottle containing a sterile preparation of ampicillin sodium and sulbactam sodium for parenteral use that contains many single doses. The Pharmacy Bulk Package is for use in a pharmacy admixture setting; it provides many single doses of ampicillin and sulbactam for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion (see DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE). FURTHER DILUTION IS REQUIRED BEFORE USE.</Description>
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<PackageDescription>1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-99) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE</PackageDescription>
<NDC11Code>55150-0118-99</NDC11Code>
<ProductNDC>55150-118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin And Sulbactam</ProprietaryName>
<NonProprietaryName>Ampicillin Sodium And Sulbactam Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
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<StartMarketingDate>20120210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090339</ApplicationNumber>
<LabelerName>Eugia US LLC</LabelerName>
<SubstanceName>AMPICILLIN SODIUM; SULBACTAM SODIUM</SubstanceName>
<StrengthNumber>100; 50</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-22</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ampicillin and sulbactam for injection, USP is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli,*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, USP is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with ampicillin and sulbactam for injection, USP due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to ampicillin and sulbactam for injection, USP should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to ampicillin and sulbactam for injection, USP. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of ampicillin and sulbactam for injection, USP and other antibacterial drugs, ampicillin and sulbactam for injection, USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Ampicillin and sulbactam for injection, USP is an injectable antibacterial combination consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. HOWEVER, THE INTENT OF THE PHARMACY BULK PACKAGE IS FOR PREPARATION OF SOLUTIONS FOR IV INFUSION ONLY. 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 parenteral combination, is available as a white to off-white, crystalline powder for reconstitution. Ampicillin and sulbactam for injection crystalline 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 and 10. 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. Each sterile Pharmacy Bulk Package contains 15 g ampicillin and sulbactam for injection (10 g ampicillin as the sodium salt plus 5 g sulbactam as the sodium salt) and approximately 1150 mg (50 mEq) sodium. Ampicillin and sulbactam for injection Pharmacy Bulk Package is a bottle containing a sterile preparation of ampicillin sodium and sulbactam sodium for parenteral use that contains many single doses. The Pharmacy Bulk Package is for use in a pharmacy admixture setting; it provides many single doses of ampicillin and sulbactam for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion (see DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE). FURTHER DILUTION IS REQUIRED BEFORE USE.</Description>
</NDC>
<NDC>
<NDCCode>71288-033-75</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (71288-033-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE</PackageDescription>
<NDC11Code>71288-0033-75</NDC11Code>
<ProductNDC>71288-033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin And Sulbactam</ProprietaryName>
<NonProprietaryName>Ampicillin Sodium And Sulbactam Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20061127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065403</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>AMPICILLIN SODIUM; SULBACTAM SODIUM</SubstanceName>
<StrengthNumber>10; 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>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061127</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.</IndicationAndUsage>
<Description>Ampicillin and Sulbactam for Injection, USP is a sterile antibacterial fixed-combination drug product 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 issodium 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 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. The pH of the solutions is between 8 and 10. 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. Each 15 g sterile Pharmacy Bulk Package contains ampicillin 10 g and sulbactam 5 g (equivalent to 10.629 g ampicillin sodium and 5.470 g sulbactam sodium). Each sterile Pharmacy Bulk Package contains approximately 1150 mg of sodium. Ampicillin and Sulbactam for Injection, USP Pharmacy Bulk Package is a bottle containing a sterile preparation for parenteral use. The Pharmacy Bulk Package is for use in a pharmacy admixture setting; it provides many single doses of Ampicillin and Sulbactam for Injection, USP for additionto suitable parenteral fluids in the preparation of admixtures for intravenous infusion. (See DIRECTIONS FOR USE - Directions for Proper Use of Pharmacy Bulk Package section). FURTHER DILUTION IS REQUIRED BEFORE USE.</Description>
</NDC>
<NDC>
<NDCCode>71335-1150-1</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1150-1) </PackageDescription>
<NDC11Code>71335-1150-01</NDC11Code>
<ProductNDC>71335-1150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desvenlafaxine Succinate</ProprietaryName>
<NonProprietaryName>Desvenlafaxine Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204172</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DESVENLAFAXINE SUCCINATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190828</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desvenlafaxine extended-release tablet is indicated for the treatment of adults with major depressive disorder (MDD) [see CLINICAL STUDIES (14)].</IndicationAndUsage>
<Description>Desvenlafaxine is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine. (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C16H25NO2 (free base) and C16H25NO2C4H6O4H2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate monohydrate is a white to creamish crystalline powder that is soluble in water. The solubility of desvenlafaxine succinate monohydrate is pH dependent. Its octanol: aqueous system (at pH 7.0) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each film-coated tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate monohydrate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 25 mg tablet consist of colloidal silicon dioxide, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 50 mg tablet consist of colloidal silicon dioxide, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 100 mg tablet consist of colloidal silicon dioxide, FD&C yellow #6 aluminum lake, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.</Description>
</NDC>
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<NDCCode>71335-1150-2</NDCCode>
<PackageDescription>28 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1150-2) </PackageDescription>
<NDC11Code>71335-1150-02</NDC11Code>
<ProductNDC>71335-1150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desvenlafaxine Succinate</ProprietaryName>
<NonProprietaryName>Desvenlafaxine Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204172</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DESVENLAFAXINE SUCCINATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desvenlafaxine extended-release tablet is indicated for the treatment of adults with major depressive disorder (MDD) [see CLINICAL STUDIES (14)].</IndicationAndUsage>
<Description>Desvenlafaxine is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine. (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C16H25NO2 (free base) and C16H25NO2C4H6O4H2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate monohydrate is a white to creamish crystalline powder that is soluble in water. The solubility of desvenlafaxine succinate monohydrate is pH dependent. Its octanol: aqueous system (at pH 7.0) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each film-coated tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate monohydrate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 25 mg tablet consist of colloidal silicon dioxide, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 50 mg tablet consist of colloidal silicon dioxide, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 100 mg tablet consist of colloidal silicon dioxide, FD&C yellow #6 aluminum lake, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.</Description>
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<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1150-3) </PackageDescription>
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<ProductNDC>71335-1150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<NonProprietaryName>Desvenlafaxine Succinate</NonProprietaryName>
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<StartMarketingDate>20170301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204172</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DESVENLAFAXINE SUCCINATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desvenlafaxine extended-release tablet is indicated for the treatment of adults with major depressive disorder (MDD) [see CLINICAL STUDIES (14)].</IndicationAndUsage>
<Description>Desvenlafaxine is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine. (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C16H25NO2 (free base) and C16H25NO2C4H6O4H2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate monohydrate is a white to creamish crystalline powder that is soluble in water. The solubility of desvenlafaxine succinate monohydrate is pH dependent. Its octanol: aqueous system (at pH 7.0) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each film-coated tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate monohydrate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 25 mg tablet consist of colloidal silicon dioxide, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 50 mg tablet consist of colloidal silicon dioxide, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 100 mg tablet consist of colloidal silicon dioxide, FD&C yellow #6 aluminum lake, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.</Description>
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<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1150-4) </PackageDescription>
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<ProductNDC>71335-1150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<StartMarketingDate>20170301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204172</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DESVENLAFAXINE SUCCINATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desvenlafaxine extended-release tablet is indicated for the treatment of adults with major depressive disorder (MDD) [see CLINICAL STUDIES (14)].</IndicationAndUsage>
<Description>Desvenlafaxine is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine. (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C16H25NO2 (free base) and C16H25NO2C4H6O4H2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate monohydrate is a white to creamish crystalline powder that is soluble in water. The solubility of desvenlafaxine succinate monohydrate is pH dependent. Its octanol: aqueous system (at pH 7.0) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each film-coated tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate monohydrate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 25 mg tablet consist of colloidal silicon dioxide, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 50 mg tablet consist of colloidal silicon dioxide, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 100 mg tablet consist of colloidal silicon dioxide, FD&C yellow #6 aluminum lake, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71335-1150-5</NDCCode>
<PackageDescription>180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1150-5) </PackageDescription>
<NDC11Code>71335-1150-05</NDC11Code>
<ProductNDC>71335-1150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desvenlafaxine Succinate</ProprietaryName>
<NonProprietaryName>Desvenlafaxine Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204172</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DESVENLAFAXINE SUCCINATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desvenlafaxine extended-release tablet is indicated for the treatment of adults with major depressive disorder (MDD) [see CLINICAL STUDIES (14)].</IndicationAndUsage>
<Description>Desvenlafaxine is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine. (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C16H25NO2 (free base) and C16H25NO2C4H6O4H2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate monohydrate is a white to creamish crystalline powder that is soluble in water. The solubility of desvenlafaxine succinate monohydrate is pH dependent. Its octanol: aqueous system (at pH 7.0) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each film-coated tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate monohydrate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 25 mg tablet consist of colloidal silicon dioxide, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 50 mg tablet consist of colloidal silicon dioxide, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Inactive ingredients for the 100 mg tablet consist of colloidal silicon dioxide, FD&C yellow #6 aluminum lake, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>72603-444-01</NDCCode>
<PackageDescription>10 BOTTLE in 1 CARTON (72603-444-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE</PackageDescription>
<NDC11Code>72603-0444-01</NDC11Code>
<ProductNDC>72603-444</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin And Sulbactam</ProprietaryName>
<NonProprietaryName>Ampicillin Sodium And Sulbactam Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20240301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065314</ApplicationNumber>
<LabelerName>NorthStar Rx, LLC</LabelerName>
<SubstanceName>AMPICILLIN SODIUM; SULBACTAM SODIUM</SubstanceName>
<StrengthNumber>10; 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>2024-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240301</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. THE INTENT OF THIS PHARMACY BULK PACKAGE IS FOR PREPARATION OF SOLUTIONS FOR IV INFUSION ONLY. 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. Each sterile Pharmacy Bulk Package contains 15 grams Ampicillin and Sulbactam for Injection (equivalent to 10 g ampicillin as the sodium salt plus 5 g sulbactam as the sodium salt). The sodium content per vial is 1150 mg (50 mEq) sodium. Ampicillin and Sulbactam for Injection Pharmacy Bulk Package is a vial containing a sterile preparation of ampicillin sodium and sulbactam sodium for parenteral use that contains many single doses. The Pharmacy Bulk Package is for use in a pharmacy admixture setting; it provides many single doses of ampicillin and sulbactam for injection for addition to suitable parenteral fluids in the preparation and administration for intravenous infusion (see DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE section). FURTHER DILUTION IS REQUIRED BEFORE USE.</Description>
</NDC>
<NDC>
<NDCCode>72603-444-10</NDCCode>
<PackageDescription>10 BOTTLE in 1 CARTON (72603-444-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE</PackageDescription>
<NDC11Code>72603-0444-10</NDC11Code>
<ProductNDC>72603-444</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin And Sulbactam</ProprietaryName>
<NonProprietaryName>Ampicillin Sodium And Sulbactam Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20240301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065314</ApplicationNumber>
<LabelerName>NorthStar Rx, LLC</LabelerName>
<SubstanceName>AMPICILLIN SODIUM; SULBACTAM SODIUM</SubstanceName>
<StrengthNumber>10; 5</StrengthNumber>
<StrengthUnit>g/1; g/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240301</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. THE INTENT OF THIS PHARMACY BULK PACKAGE IS FOR PREPARATION OF SOLUTIONS FOR IV INFUSION ONLY. 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. Each sterile Pharmacy Bulk Package contains 15 grams Ampicillin and Sulbactam for Injection (equivalent to 10 g ampicillin as the sodium salt plus 5 g sulbactam as the sodium salt). The sodium content per vial is 1150 mg (50 mEq) sodium. Ampicillin and Sulbactam for Injection Pharmacy Bulk Package is a vial containing a sterile preparation of ampicillin sodium and sulbactam sodium for parenteral use that contains many single doses. The Pharmacy Bulk Package is for use in a pharmacy admixture setting; it provides many single doses of ampicillin and sulbactam for injection for addition to suitable parenteral fluids in the preparation and administration for intravenous infusion (see DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE section). FURTHER DILUTION IS REQUIRED BEFORE USE.</Description>
</NDC>
<NDC>
<NDCCode>76519-1150-9</NDCCode>
<PackageDescription>90 TABLET in 1 CONTAINER (76519-1150-9) </PackageDescription>
<NDC11Code>76519-1150-09</NDC11Code>
<ProductNDC>76519-1150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077783</ApplicationNumber>
<LabelerName>H. J. Harkins Company Inc.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Epilepsy. Adjunctive Therapy. Lamotrigine tablets, USP is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older:. Monotherapy. Lamotrigine tablets, USP is indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED). Safety and effectiveness of lamotrigine tablets, USP have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs. 1.2 Bipolar Disorder. Lamotrigine tablets, USP is indicated for the maintenance treatment of Bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy [SEE CLINICAL STUDIES (14.1)]. Limitations of Use. Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine tablets, USP in the acute treatment of mood episodes has not been established.</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3, 5-diamino-6-(2, 3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKaof 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine Tablets, USP are supplied for oral administration as 25 mg (light pink), 100 mg (light pink), 150 mg (light pink), and 200 mg (light pink) tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, povidone, sodium starch glycolate, black iron oxide, iron oxide red and yellow iron oxide. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>51552-0004-7</NDCCode>
<PackageDescription>2500 g in 1 CONTAINER (51552-0004-7)</PackageDescription>
<NDC11Code>51552-0004-07</NDC11Code>
<ProductNDC>51552-0004</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Polyethylene Glycol 8000</NonProprietaryName>
<DosageFormName>GRANULE</DosageFormName>
<StartMarketingDate>20040901</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 8000</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51552-0006-7</NDCCode>
<PackageDescription>1000 g in 1 CONTAINER (51552-0006-7) </PackageDescription>
<NDC11Code>51552-0006-07</NDC11Code>
<ProductNDC>51552-0006</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Progesterone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19980401</StartMarketingDate>
<EndMarketingDate>20261219</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>PROGESTERONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<StartMarketingDatePackage>01-APR-98</StartMarketingDatePackage>
<EndMarketingDatePackage>24-JUL-24</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>51552-0007-7</NDCCode>
<PackageDescription>2500 g in 1 CONTAINER (51552-0007-7) </PackageDescription>
<NDC11Code>51552-0007-07</NDC11Code>
<ProductNDC>51552-0007</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Fatty Acid</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<StartMarketingDate>19980401</StartMarketingDate>
<EndMarketingDate>20240523</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>PALM KERNEL OIL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<StartMarketingDatePackage>01-APR-98</StartMarketingDatePackage>
<EndMarketingDatePackage>23-MAY-24</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>51552-0008-7</NDCCode>
<PackageDescription>2500 g in 1 CONTAINER (51552-0008-7) </PackageDescription>
<NDC11Code>51552-0008-07</NDC11Code>
<ProductNDC>51552-0008</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Peg Blend</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<StartMarketingDate>19980401</StartMarketingDate>
<EndMarketingDate>20260509</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 400; POLYETHYLENE GLYCOL 8000; POLYSORBATE 80</SubstanceName>
<StrengthNumber>1; 1; 1</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<StartMarketingDatePackage>01-APR-98</StartMarketingDatePackage>
<EndMarketingDatePackage>16-APR-26</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>51552-0018-7</NDCCode>
<PackageDescription>2500 g in 1 CONTAINER (51552-0018-7)</PackageDescription>
<NDC11Code>51552-0018-07</NDC11Code>
<ProductNDC>51552-0018</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20040901</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51552-0020-7</NDCCode>
<PackageDescription>1000 g in 1 CONTAINER (51552-0020-7) </PackageDescription>
<NDC11Code>51552-0020-07</NDC11Code>
<ProductNDC>51552-0020</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20040901</StartMarketingDate>
<EndMarketingDate>20250613</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<StartMarketingDatePackage>01-SEP-04</StartMarketingDatePackage>
<EndMarketingDatePackage>13-JUN-25</EndMarketingDatePackage>
</NDC>
</NDCList>