{
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"NDCCode": "55154-4250-0",
"PackageDescription": "10 BLISTER PACK in 1 BAG (55154-4250-0) > 1 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "55154-4250-00",
"ProductNDC": "55154-4250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cardizem",
"NonProprietaryName": "Diltiazem Hydrochloride",
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"RouteName": "ORAL",
"StartMarketingDate": "20010411",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020062",
"LabelerName": "Cardinal Health",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
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"ProductNdcExcludeFlag": "E",
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},
{
"NDCCode": "51927-4250-0",
"PackageDescription": "1 g in 1 CONTAINER (51927-4250-0)",
"NDC11Code": "51927-4250-00",
"ProductNDC": "51927-4250",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Liothyronine Sodium Dilution",
"DosageFormName": "POWDER",
"StartMarketingDate": "20071126",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Professional Compounding Centers of America dba PCCA",
"SubstanceName": "LIOTHYRONINE SODIUM",
"StrengthNumber": ".1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "54868-4250-0",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (54868-4250-0)",
"NDC11Code": "54868-4250-00",
"ProductNDC": "54868-4250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prometrium",
"NonProprietaryName": "Progesterone",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20030314",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019781",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "PROGESTERONE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Progesterone [Chemical/Ingredient],Progesterone [EPC]",
"Status": "Deprecated",
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"ProductNdcExcludeFlag": "E",
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"IndicationAndUsage": "PROMETRIUM Capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.",
"Description": "PROMETRIUM® (progesterone, USP) Capsules contain micronized progesterone for oral administration. Progesterone has a molecular weight of 314.47 and a molecular formula of C21H30O2. Progesterone (pregn-4-ene-3, 20-dione) is a white or creamy white, odorless, crystalline powder practically insoluble in water, soluble in alcohol, acetone and dioxane and sparingly soluble in vegetable oils, stable in air, melting between 126° and 131°C. The structural formula is. Progesterone is synthesized from a starting material from a plant source and is chemically identical to progesterone of human ovarian origin. PROMETRIUM Capsules are available in multiple strengths to afford dosage flexibility for optimum management. PROMETRIUM Capsules contain 100 mg or 200 mg micronized progesterone. The inactive ingredients for PROMETRIUM Capsules 100 mg include: peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium dioxide USP, D&C Yellow No. 10, and FD&C Red No. 40. The inactive ingredients for PROMETRIUM Capsules 200 mg include: peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium dioxide USP, D&C Yellow No. 10, and FD&C Yellow No. 6."
},
{
"NDCCode": "62670-4250-0",
"PackageDescription": "29 mL in 1 BOTTLE (62670-4250-0)",
"NDC11Code": "62670-4250-00",
"ProductNDC": "62670-4250",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Hand",
"ProprietaryNameSuffix": "Gorgeous Grape",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120308",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "68",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2014-04-03"
},
{
"NDCCode": "63518-4250-0",
"PackageDescription": "125 mL in 1 VIAL (63518-4250-0) ",
"NDC11Code": "63518-4250-00",
"ProductNDC": "63518-4250",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Sodium Molybdate",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20151111",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Curium Netherlands B.V.",
"SubstanceName": "SODIUM MOLYBDATE MO-99",
"StrengthNumber": "60",
"StrengthUnit": "Ci/125mL",
"Status": "Unfinished",
"LastUpdate": "2025-04-01",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "11-NOV-15"
},
{
"NDCCode": "70518-4250-0",
"PackageDescription": "30 CAPSULE in 1 BLISTER PACK (70518-4250-0) ",
"NDC11Code": "70518-4250-00",
"ProductNDC": "70518-4250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cephalexin",
"NonProprietaryName": "Cephalexin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20241231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065253",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "CEPHALEXIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2026-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "Cephalexin capsules are a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: 1 Respiratory tract infection ( 1.1) , 2 Otitis media ( 1.2) , 3 Skin and skin structure infections ( 1.3) , 4 Bone infections ( 1.4) , 5 Genitourinary tract infections ( 1.5) .",
"Description": "Cephalexin capsules, USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C 16H 17N 3O 4SH 2O and the molecular weight is 365.41. Cephalexin has the following structural formula:. Each capsule contains cephalexin monohydrate equivalent to 250 mg or 500 mg of cephalexin. The capsules also contain the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6, gelatin, magnesium stearate, titanium dioxide, and sodium lauryl sulfate. FDA approved dissolution test specifications differs from the USP."
},
{
"NDCCode": "51754-4250-3",
"PackageDescription": "10 SYRINGE, PLASTIC in 1 CARTON (51754-4250-3) > 5 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "51754-4250-03",
"ProductNDC": "51754-4250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Akovaz",
"NonProprietaryName": "Ephedrine Sulfate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208289",
"LabelerName": "Exela Pharma Sciences, LLC",
"SubstanceName": "EPHEDRINE SULFATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2022-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210510",
"SamplePackage": "N",
"IndicationAndUsage": "AKOVAZ (ephedrine sulfate injection) is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.",
"Description": "Ephedrine is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent. AKOVAZ (ephedrine sulfate injection) is a clear, colorless, sterile solution for intravenous injection. The chemical name of ephedrine sulfate is benzenemethanol, α-[1-(methylamino)ethyl]-, [R-(R*,S*)]-, sulfate (2:1) (salt), and the molecular weight is 428.5 g/mol. Its structural formula is depicted below:. Ephedrine sulfate is freely soluble in water and ethanol, very slightly soluble in chloroform, and practically insoluble in ether. Each mL of the 50 mg/mL strength contains ephedrine sulfate 50 mg (equivalent to 38 mg ephedrine base) in water for injection. The pH is adjusted with sodium hydroxide and/or glacial acetic acid if necessary. The pH range is 4.5 to 7.0. The 50 mg/mL vial must be diluted before intravenous administration. Each mL of the 5 mL single-dose prefilled syringe contains 5 mg (equivalent to 3.8 mg ephedrine base) and 9 mg Sodium Chloride, USP in Water for Injection. The pH range is 4.5 to 6.5."
},
{
"NDCCode": "67684-4250-1",
"PackageDescription": "1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-1) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE",
"NDC11Code": "67684-4250-01",
"ProductNDC": "67684-4250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elucirem",
"NonProprietaryName": "Gadopiclenol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216986",
"LabelerName": "Guerbet LLC",
"SubstanceName": "GADOPICLENOL",
"StrengthNumber": "485.1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220921",
"SamplePackage": "N",
"IndicationAndUsage": "ELUCIREM is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues),, 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).",
"Description": "ELUCIREM (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of ELUCIREM are provided in Table 2."
},
{
"NDCCode": "67684-4250-2",
"PackageDescription": "25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-2) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE",
"NDC11Code": "67684-4250-02",
"ProductNDC": "67684-4250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elucirem",
"NonProprietaryName": "Gadopiclenol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216986",
"LabelerName": "Guerbet LLC",
"SubstanceName": "GADOPICLENOL",
"StrengthNumber": "485.1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220921",
"SamplePackage": "N",
"IndicationAndUsage": "ELUCIREM is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues),, 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).",
"Description": "ELUCIREM (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of ELUCIREM are provided in Table 2."
},
{
"NDCCode": "67684-4250-3",
"PackageDescription": "1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-3) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE",
"NDC11Code": "67684-4250-03",
"ProductNDC": "67684-4250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elucirem",
"NonProprietaryName": "Gadopiclenol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216986",
"LabelerName": "Guerbet LLC",
"SubstanceName": "GADOPICLENOL",
"StrengthNumber": "485.1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220921",
"SamplePackage": "N",
"IndicationAndUsage": "ELUCIREM is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues),, 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).",
"Description": "ELUCIREM (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of ELUCIREM are provided in Table 2."
},
{
"NDCCode": "67684-4250-4",
"PackageDescription": "25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-4) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE",
"NDC11Code": "67684-4250-04",
"ProductNDC": "67684-4250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elucirem",
"NonProprietaryName": "Gadopiclenol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216986",
"LabelerName": "Guerbet LLC",
"SubstanceName": "GADOPICLENOL",
"StrengthNumber": "485.1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220921",
"SamplePackage": "N",
"IndicationAndUsage": "ELUCIREM is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues),, 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).",
"Description": "ELUCIREM (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of ELUCIREM are provided in Table 2."
},
{
"NDCCode": "67684-4250-5",
"PackageDescription": "1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-5) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE",
"NDC11Code": "67684-4250-05",
"ProductNDC": "67684-4250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elucirem",
"NonProprietaryName": "Gadopiclenol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216986",
"LabelerName": "Guerbet LLC",
"SubstanceName": "GADOPICLENOL",
"StrengthNumber": "485.1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220921",
"SamplePackage": "N",
"IndicationAndUsage": "ELUCIREM is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues),, 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).",
"Description": "ELUCIREM (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of ELUCIREM are provided in Table 2."
},
{
"NDCCode": "67684-4250-6",
"PackageDescription": "6 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-6) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE",
"NDC11Code": "67684-4250-06",
"ProductNDC": "67684-4250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elucirem",
"NonProprietaryName": "Gadopiclenol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216986",
"LabelerName": "Guerbet LLC",
"SubstanceName": "GADOPICLENOL",
"StrengthNumber": "485.1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220921",
"SamplePackage": "N",
"IndicationAndUsage": "ELUCIREM is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues),, 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).",
"Description": "ELUCIREM (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of ELUCIREM are provided in Table 2."
},
{
"NDCCode": "67684-4250-7",
"PackageDescription": "12 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-7) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE",
"NDC11Code": "67684-4250-07",
"ProductNDC": "67684-4250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elucirem",
"NonProprietaryName": "Gadopiclenol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216986",
"LabelerName": "Guerbet LLC",
"SubstanceName": "GADOPICLENOL",
"StrengthNumber": "485.1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220921",
"SamplePackage": "N",
"IndicationAndUsage": "ELUCIREM is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues),, 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).",
"Description": "ELUCIREM (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of ELUCIREM are provided in Table 2."
},
{
"NDCCode": "68071-4250-3",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68071-4250-3) ",
"NDC11Code": "68071-4250-03",
"ProductNDC": "68071-4250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076565",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20180124",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: (1): 1 Major Depressive Disorder (MDD), 2 Generalized Anxiety Disorder (GAD), 3 Social Anxiety Disorder (SAD), 4 Panic Disorder (PD).",
"Description": "Venlafaxine hydrochloride extended-release capsules USP are an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]- p-methoxybenzyl] cyclohexanol hydrochloride. The structural formula is shown below. C 17H 27NO 2HCl M.W. 313.87. Venlafaxine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of black iron oxide, dibutyl sebacate, ethylcellulose, gelatin, polyethylene glycol, povidone, propylene glycol, shellac, sugar spheres (which contain sucrose and corn starch), sunset yellow FCF FD&C yellow 6, talc, and titanium dioxide. The 37.5 mg capsules also contain D&C yellow 10 and potassium hydroxide, the 75 mg capsules also contain D&C yellow 10 and may contain potassium hydroxide, and the 150 mg capsules also contain potassium hydroxide."
},
{
"NDCCode": "55154-0109-0",
"PackageDescription": "10 BLISTER PACK in 1 BAG (55154-0109-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "55154-0109-00",
"ProductNDC": "55154-0109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Biaxin",
"NonProprietaryName": "Clarithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19911031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050662",
"LabelerName": "Cardinal Health",
"SubstanceName": "CLARITHROMYCIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-03-14",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "55154-0113-0",
"PackageDescription": "10 BLISTER PACK in 1 BAG (55154-0113-0) > 1 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "55154-0113-00",
"ProductNDC": "55154-0113",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Depakote",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100607",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019680",
"LabelerName": "Cardinal Health",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "55154-0158-0",
"PackageDescription": "10 BLISTER PACK in 1 BAG (55154-0158-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "55154-0158-00",
"ProductNDC": "55154-0158",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin",
"NonProprietaryName": "Rosuvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250714",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207616",
"LabelerName": "Cardinal Health 107, LLC",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250714",
"SamplePackage": "N",
"IndicationAndUsage": "Rosuvastatin tablets are indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. Reduce LDL-C and slow the progression of atherosclerosis in adults. Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia.",
"Description": "Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is (3R, 5S, 6E) -7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid calcium salt with the following structural formula:. The molecular formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP is a white or almost white hygroscopic powder that is sparingly soluble in methanol, slightly soluble in water, practically insoluble in anhydrous ethanol. Rosuvastatin tablets USP for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, talc, titanium dioxide and triacetin. Additionally 5 mg tablets contain FD&C yellow #5/tartrazine aluminum lake and 10 mg, 20 mg and 40 mg tablets contain FD&C yellow #6/sunset yellow FCF aluminum lake. USP Dissolution test is pending."
},
{
"NDCCode": "55154-0159-0",
"PackageDescription": "10 BLISTER PACK in 1 BAG (55154-0159-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "55154-0159-00",
"ProductNDC": "55154-0159",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin",
"NonProprietaryName": "Rosuvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251016",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207616",
"LabelerName": "Cardinal Health 107, LLC",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251016",
"SamplePackage": "N",
"IndicationAndUsage": "Rosuvastatin tablets are indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. Reduce LDL-C and slow the progression of atherosclerosis in adults. Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia.",
"Description": "Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is (3R, 5S, 6E) -7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid calcium salt with the following structural formula:. The molecular formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP is a white or almost white hygroscopic powder that is sparingly soluble in methanol, slightly soluble in water, practically insoluble in anhydrous ethanol. Rosuvastatin tablets USP for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, talc, titanium dioxide and triacetin. Additionally 5 mg tablets contain FD&C yellow #5/tartrazine aluminum lake and 10 mg, 20 mg and 40 mg tablets contain FD&C yellow #6/sunset yellow FCF aluminum lake. USP Dissolution test is pending."
},
{
"NDCCode": "55154-0160-0",
"PackageDescription": "10 BLISTER PACK in 1 BAG (55154-0160-0) / 1 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "55154-0160-00",
"ProductNDC": "55154-0160",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260710",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204519",
"LabelerName": "Cardinal Health 107, LLC",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260710",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib is indicated.",
"Description": "Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure. Celecoxib is a white or almost white crystalline powder with a pKa of about 11 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and soluble to freely soluble in ethanol, soluble in methylene chloride, practically insoluble in water. The inactive ingredients in celecoxib capsule include: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate, titanium dioxide and gelatin. Details of non-volatile components of the imprinting ink are given below. 50 mg capsule contains shellac, propylene glycol and red iron oxide. 100 mg capsule contains shellac, propylene glycol and FD & C Blue No. # 2 aluminum lake. 200 mg capsule contains shellac, propylene glycol and yellow iron oxide. 400 mg capsule contains shellac, propylene glycol, titanium dioxide, yellow iron oxide and FD & C Blue No. # 2 aluminum lake."
},
{
"NDCCode": "55154-0161-0",
"PackageDescription": "10 BLISTER PACK in 1 BAG (55154-0161-0) / 1 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "55154-0161-00",
"ProductNDC": "55154-0161",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mycophenolate Mofetil",
"NonProprietaryName": "Mycophenolate Mofetil",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200197",
"LabelerName": "Cardinal Health 107, LLC",
"SubstanceName": "MYCOPHENOLATE MOFETIL",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260914",
"SamplePackage": "N",
"IndicationAndUsage": "Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.",
"Description": "Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C 23H 31NO 7, a molecular weight of 433.50, and the following structural formula:. Mycophenolate mofetil is a white to off-white crystalline powder. It is slightly soluble in water (43 mcg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. Mycophenolate mofetil is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of mycophenolate mofetil. Inactive ingredients in Mycophenolate mofetil capsules USP 250 mg include croscarmellose sodium, pregelatinized starch, povidone (K-90), isopropyl alcohol and magnesium stearate. The capsule shells contain gelatin, sodium lauryl sulphate, FD&C blue 2, red iron oxide, yellow iron oxide and titanium dioxide. The capsule is printed with edible black ink comprised of black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, strong ammonia solution. Inactive ingredients in mycophenolate mofetil tablets USP 500 mg include croscarmellose sodium, povidone (K-90), isopropyl alcohol, microcrystalline cellulose, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, red iron oxide, black iron oxide, and yellow iron oxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "55154-0180-0",
"PackageDescription": "10 BLISTER PACK in 1 BAG (55154-0180-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "55154-0180-00",
"ProductNDC": "55154-0180",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250519",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078040",
"LabelerName": "Cardinal Health 107, LLC",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250519",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone is an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).",
"Description": "Risperidone Tablets contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone, USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Each risperidone tablet intended for oral administration contains 0.25 mg or 0.5 mg or 1 mg or 2 mg or 3 mg or 4 mg of risperidone. Additionally each tablet also contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium lauryl sulfate, and titanium dioxide. Additionally each 0.25 mg tablet contains iron oxide red and iron oxide yellow, 0.5 mg tablet contains iron oxide red, 2 mg tablet contains FD&C yellow # 6/sunset yellow FCF aluminum lake, 3 mg tablet contains D&C yellow # 10 aluminum lake and 4 mg tablet contains D&C yellow # 10 aluminum lake and FD&C blue # 2/ indigo carmine aluminum lake."
},
{
"NDCCode": "55154-0181-0",
"PackageDescription": "10 BLISTER PACK in 1 BAG (55154-0181-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "55154-0181-00",
"ProductNDC": "55154-0181",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250506",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209603",
"LabelerName": "Cardinal Health 107, LLC",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250506",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol HCl tablets are indicated in the management of hypertension. Labetalol HCl tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.",
"Description": "Labetalol Hydrochloride Tablets, USP are adrenergic receptor blocking agents that have both selective alpha1-adrenergic and non-selective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl), USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl) amino] ethyl] benzamide monohydrochloride and it has the following structural formula. Labetalol HCl, USP has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl, USP is a white to off-white crystalline powder, soluble in water. Each tablet, for oral administration, contains 100 mg, 200 mg, 300 mg or 400 mg of labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide."
},
{
"NDCCode": "55154-0182-0",
"PackageDescription": "10 BLISTER PACK in 1 BAG (55154-0182-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "55154-0182-00",
"ProductNDC": "55154-0182",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250506",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209603",
"LabelerName": "Cardinal Health 107, LLC",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250506",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol HCl tablets are indicated in the management of hypertension. Labetalol HCl tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.",
"Description": "Labetalol Hydrochloride Tablets, USP are adrenergic receptor blocking agents that have both selective alpha1-adrenergic and non-selective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl), USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl) amino] ethyl] benzamide monohydrochloride and it has the following structural formula. Labetalol HCl, USP has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl, USP is a white to off-white crystalline powder, soluble in water. Each tablet, for oral administration, contains 100 mg, 200 mg, 300 mg or 400 mg of labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide."
},
{
"NDCCode": "55154-0183-0",
"PackageDescription": "10 BLISTER PACK in 1 BAG (55154-0183-0) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "55154-0183-00",
"ProductNDC": "55154-0183",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Sr",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202304",
"LabelerName": "Cardinal Health 107, LLC",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250609",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release (SR) tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)]. The efficacy of bupropion hydrochloride extended-release (SR) tablets in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)].",
"Description": "Bupropion hydrochloride extended-release (SR) tablets, USP an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNO∙HCl. Bupropion hydrochloride, USP powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release (SR) tablets, USP are supplied for oral administration as 100-mg (blue), 150-mg (purple), and 200-mg (pink), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. In addition, the 100-mg tablet contains FD&C Blue #2/Indigo Carmine Aluminum Lake, the 150-mg tablet contains FD&C Blue #2/Indigo Carmine Aluminum Lake and FD&C Red #40/Allura Red Ac Aluminum Lake, and the 200-mg tablet contains ferrosoferric oxide and iron oxide red. Meet USP Dissolution Test 7."
},
{
"NDCCode": "55154-0184-0",
"PackageDescription": "10 BLISTER PACK in 1 BAG (55154-0184-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "55154-0184-00",
"ProductNDC": "55154-0184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250506",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209603",
"LabelerName": "Cardinal Health 107, LLC",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250506",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol HCl tablets are indicated in the management of hypertension. Labetalol HCl tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.",
"Description": "Labetalol Hydrochloride Tablets, USP are adrenergic receptor blocking agents that have both selective alpha1-adrenergic and non-selective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl), USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl) amino] ethyl] benzamide monohydrochloride and it has the following structural formula. Labetalol HCl, USP has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl, USP is a white to off-white crystalline powder, soluble in water. Each tablet, for oral administration, contains 100 mg, 200 mg, 300 mg or 400 mg of labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide."
},
{
"NDCCode": "55154-0186-0",
"PackageDescription": "10 BLISTER PACK in 1 BAG (55154-0186-0) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "55154-0186-00",
"ProductNDC": "55154-0186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250709",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040858",
"LabelerName": "Cardinal Health 107, LLC",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250709",
"SamplePackage": "N",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain magnesium stearate, microcrystalline cellulose, orange lake blend, silicon dioxide, and sodium starch glycolate. The orange lake blend consists of FD&C yellow #6."
},
{
"NDCCode": "55154-0187-0",
"PackageDescription": "10 BLISTER PACK in 1 BAG (55154-0187-0) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "55154-0187-00",
"ProductNDC": "55154-0187",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250709",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040858",
"LabelerName": "Cardinal Health 107, LLC",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250709",
"SamplePackage": "N",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain magnesium stearate, microcrystalline cellulose, orange lake blend, silicon dioxide, and sodium starch glycolate. The orange lake blend consists of FD&C yellow #6."
},
{
"NDCCode": "55154-0188-0",
"PackageDescription": "10 BLISTER PACK in 1 BAG (55154-0188-0) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "55154-0188-00",
"ProductNDC": "55154-0188",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250828",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076301",
"LabelerName": "Cardinal Health 107, LLC",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-09-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250828",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose , 2 itchy, watery eyes, 3 sneezing , 4 itching of the nose or throat."
},
{
"NDCCode": "55154-0189-0",
"PackageDescription": "10 BLISTER PACK in 1 BAG (55154-0189-0) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "55154-0189-00",
"ProductNDC": "55154-0189",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine Hydrochloride",
"NonProprietaryName": "Clonidine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077901",
"LabelerName": "Cardinal Health 107, LLC",
"SubstanceName": "CLONIDINE HYDROCHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251009",
"SamplePackage": "N",
"IndicationAndUsage": "Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets, USP may be employed alone or concomitantly with other antihypertensive agents."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>55154-4250-0</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BAG (55154-4250-0) > 1 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55154-4250-00</NDC11Code>
<ProductNDC>55154-4250</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cardizem</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010411</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020062</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51927-4250-0</NDCCode>
<PackageDescription>1 g in 1 CONTAINER (51927-4250-0)</PackageDescription>
<NDC11Code>51927-4250-00</NDC11Code>
<ProductNDC>51927-4250</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Liothyronine Sodium Dilution</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20071126</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Professional Compounding Centers of America dba PCCA</LabelerName>
<SubstanceName>LIOTHYRONINE SODIUM</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54868-4250-0</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (54868-4250-0)</PackageDescription>
<NDC11Code>54868-4250-00</NDC11Code>
<ProductNDC>54868-4250</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prometrium</ProprietaryName>
<NonProprietaryName>Progesterone</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030314</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019781</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>PROGESTERONE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Progesterone [Chemical/Ingredient],Progesterone [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>PROMETRIUM Capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.</IndicationAndUsage>
<Description>PROMETRIUM® (progesterone, USP) Capsules contain micronized progesterone for oral administration. Progesterone has a molecular weight of 314.47 and a molecular formula of C21H30O2. Progesterone (pregn-4-ene-3, 20-dione) is a white or creamy white, odorless, crystalline powder practically insoluble in water, soluble in alcohol, acetone and dioxane and sparingly soluble in vegetable oils, stable in air, melting between 126° and 131°C. The structural formula is. Progesterone is synthesized from a starting material from a plant source and is chemically identical to progesterone of human ovarian origin. PROMETRIUM Capsules are available in multiple strengths to afford dosage flexibility for optimum management. PROMETRIUM Capsules contain 100 mg or 200 mg micronized progesterone. The inactive ingredients for PROMETRIUM Capsules 100 mg include: peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium dioxide USP, D&C Yellow No. 10, and FD&C Red No. 40. The inactive ingredients for PROMETRIUM Capsules 200 mg include: peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium dioxide USP, D&C Yellow No. 10, and FD&C Yellow No. 6.</Description>
</NDC>
<NDC>
<NDCCode>62670-4250-0</NDCCode>
<PackageDescription>29 mL in 1 BOTTLE (62670-4250-0)</PackageDescription>
<NDC11Code>62670-4250-00</NDC11Code>
<ProductNDC>62670-4250</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Hand</ProprietaryName>
<ProprietaryNameSuffix>Gorgeous Grape</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120308</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>68</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-04-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>63518-4250-0</NDCCode>
<PackageDescription>125 mL in 1 VIAL (63518-4250-0) </PackageDescription>
<NDC11Code>63518-4250-00</NDC11Code>
<ProductNDC>63518-4250</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Sodium Molybdate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20151111</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Curium Netherlands B.V.</LabelerName>
<SubstanceName>SODIUM MOLYBDATE MO-99</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>Ci/125mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-04-01</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>11-NOV-15</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>70518-4250-0</NDCCode>
<PackageDescription>30 CAPSULE in 1 BLISTER PACK (70518-4250-0) </PackageDescription>
<NDC11Code>70518-4250-00</NDC11Code>
<ProductNDC>70518-4250</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cephalexin</ProprietaryName>
<NonProprietaryName>Cephalexin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241231</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065253</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>CEPHALEXIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cephalexin capsules are a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: 1 Respiratory tract infection ( 1.1) , 2 Otitis media ( 1.2) , 3 Skin and skin structure infections ( 1.3) , 4 Bone infections ( 1.4) , 5 Genitourinary tract infections ( 1.5) .</IndicationAndUsage>
<Description>Cephalexin capsules, USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C 16H 17N 3O 4SH 2O and the molecular weight is 365.41. Cephalexin has the following structural formula:. Each capsule contains cephalexin monohydrate equivalent to 250 mg or 500 mg of cephalexin. The capsules also contain the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6, gelatin, magnesium stearate, titanium dioxide, and sodium lauryl sulfate. FDA approved dissolution test specifications differs from the USP.</Description>
</NDC>
<NDC>
<NDCCode>51754-4250-3</NDCCode>
<PackageDescription>10 SYRINGE, PLASTIC in 1 CARTON (51754-4250-3) > 5 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>51754-4250-03</NDC11Code>
<ProductNDC>51754-4250</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Akovaz</ProprietaryName>
<NonProprietaryName>Ephedrine Sulfate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210510</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208289</ApplicationNumber>
<LabelerName>Exela Pharma Sciences, LLC</LabelerName>
<SubstanceName>EPHEDRINE SULFATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AKOVAZ (ephedrine sulfate injection) is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.</IndicationAndUsage>
<Description>Ephedrine is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent. AKOVAZ (ephedrine sulfate injection) is a clear, colorless, sterile solution for intravenous injection. The chemical name of ephedrine sulfate is benzenemethanol, α-[1-(methylamino)ethyl]-, [R-(R*,S*)]-, sulfate (2:1) (salt), and the molecular weight is 428.5 g/mol. Its structural formula is depicted below:. Ephedrine sulfate is freely soluble in water and ethanol, very slightly soluble in chloroform, and practically insoluble in ether. Each mL of the 50 mg/mL strength contains ephedrine sulfate 50 mg (equivalent to 38 mg ephedrine base) in water for injection. The pH is adjusted with sodium hydroxide and/or glacial acetic acid if necessary. The pH range is 4.5 to 7.0. The 50 mg/mL vial must be diluted before intravenous administration. Each mL of the 5 mL single-dose prefilled syringe contains 5 mg (equivalent to 3.8 mg ephedrine base) and 9 mg Sodium Chloride, USP in Water for Injection. The pH range is 4.5 to 6.5.</Description>
</NDC>
<NDC>
<NDCCode>67684-4250-1</NDCCode>
<PackageDescription>1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-1) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE</PackageDescription>
<NDC11Code>67684-4250-01</NDC11Code>
<ProductNDC>67684-4250</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elucirem</ProprietaryName>
<NonProprietaryName>Gadopiclenol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216986</ApplicationNumber>
<LabelerName>Guerbet LLC</LabelerName>
<SubstanceName>GADOPICLENOL</SubstanceName>
<StrengthNumber>485.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELUCIREM is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues),, 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).</IndicationAndUsage>
<Description>ELUCIREM (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of ELUCIREM are provided in Table 2.</Description>
</NDC>
<NDC>
<NDCCode>67684-4250-2</NDCCode>
<PackageDescription>25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-2) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE</PackageDescription>
<NDC11Code>67684-4250-02</NDC11Code>
<ProductNDC>67684-4250</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elucirem</ProprietaryName>
<NonProprietaryName>Gadopiclenol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216986</ApplicationNumber>
<LabelerName>Guerbet LLC</LabelerName>
<SubstanceName>GADOPICLENOL</SubstanceName>
<StrengthNumber>485.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>ELUCIREM is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues),, 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).</IndicationAndUsage>
<Description>ELUCIREM (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of ELUCIREM are provided in Table 2.</Description>
</NDC>
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<IndicationAndUsage>ELUCIREM is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues),, 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).</IndicationAndUsage>
<Description>ELUCIREM (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of ELUCIREM are provided in Table 2.</Description>
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<IndicationAndUsage>ELUCIREM is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues),, 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).</IndicationAndUsage>
<Description>ELUCIREM (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of ELUCIREM are provided in Table 2.</Description>
</NDC>
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<IndicationAndUsage>ELUCIREM is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues),, 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).</IndicationAndUsage>
<Description>ELUCIREM (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of ELUCIREM are provided in Table 2.</Description>
</NDC>
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<SubstanceName>GADOPICLENOL</SubstanceName>
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<IndicationAndUsage>ELUCIREM is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues),, 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).</IndicationAndUsage>
<Description>ELUCIREM (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of ELUCIREM are provided in Table 2.</Description>
</NDC>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELUCIREM is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues),, 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).</IndicationAndUsage>
<Description>ELUCIREM (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of ELUCIREM are provided in Table 2.</Description>
</NDC>
<NDC>
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<NDC11Code>68071-4250-03</NDC11Code>
<ProductNDC>68071-4250</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076565</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: (1): 1 Major Depressive Disorder (MDD), 2 Generalized Anxiety Disorder (GAD), 3 Social Anxiety Disorder (SAD), 4 Panic Disorder (PD).</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules USP are an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]- p-methoxybenzyl] cyclohexanol hydrochloride. The structural formula is shown below. C 17H 27NO 2HCl M.W. 313.87. Venlafaxine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of black iron oxide, dibutyl sebacate, ethylcellulose, gelatin, polyethylene glycol, povidone, propylene glycol, shellac, sugar spheres (which contain sucrose and corn starch), sunset yellow FCF FD&C yellow 6, talc, and titanium dioxide. The 37.5 mg capsules also contain D&C yellow 10 and potassium hydroxide, the 75 mg capsules also contain D&C yellow 10 and may contain potassium hydroxide, and the 150 mg capsules also contain potassium hydroxide.</Description>
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<NDC>
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<PackageDescription>10 BLISTER PACK in 1 BAG (55154-0109-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Biaxin</ProprietaryName>
<NonProprietaryName>Clarithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19911031</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050662</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>CLARITHROMYCIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-14</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
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<ProductNDC>55154-0113</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Depakote</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100607</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019680</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-07</LastUpdate>
</NDC>
<NDC>
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<PackageDescription>10 BLISTER PACK in 1 BAG (55154-0158-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
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<ProductNDC>55154-0158</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin</ProprietaryName>
<NonProprietaryName>Rosuvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250714</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207616</ApplicationNumber>
<LabelerName>Cardinal Health 107, LLC</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rosuvastatin tablets are indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. Reduce LDL-C and slow the progression of atherosclerosis in adults. Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia.</IndicationAndUsage>
<Description>Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is (3R, 5S, 6E) -7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid calcium salt with the following structural formula:. The molecular formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP is a white or almost white hygroscopic powder that is sparingly soluble in methanol, slightly soluble in water, practically insoluble in anhydrous ethanol. Rosuvastatin tablets USP for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, talc, titanium dioxide and triacetin. Additionally 5 mg tablets contain FD&C yellow #5/tartrazine aluminum lake and 10 mg, 20 mg and 40 mg tablets contain FD&C yellow #6/sunset yellow FCF aluminum lake. USP Dissolution test is pending.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin</ProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251016</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rosuvastatin tablets are indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. Reduce LDL-C and slow the progression of atherosclerosis in adults. Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia.</IndicationAndUsage>
<Description>Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is (3R, 5S, 6E) -7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid calcium salt with the following structural formula:. The molecular formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP is a white or almost white hygroscopic powder that is sparingly soluble in methanol, slightly soluble in water, practically insoluble in anhydrous ethanol. Rosuvastatin tablets USP for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, talc, titanium dioxide and triacetin. Additionally 5 mg tablets contain FD&C yellow #5/tartrazine aluminum lake and 10 mg, 20 mg and 40 mg tablets contain FD&C yellow #6/sunset yellow FCF aluminum lake. USP Dissolution test is pending.</Description>
</NDC>
<NDC>
<NDCCode>55154-0160-0</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BAG (55154-0160-0) / 1 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55154-0160-00</NDC11Code>
<ProductNDC>55154-0160</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260710</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204519</ApplicationNumber>
<LabelerName>Cardinal Health 107, LLC</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib is indicated.</IndicationAndUsage>
<Description>Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure. Celecoxib is a white or almost white crystalline powder with a pKa of about 11 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and soluble to freely soluble in ethanol, soluble in methylene chloride, practically insoluble in water. The inactive ingredients in celecoxib capsule include: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate, titanium dioxide and gelatin. Details of non-volatile components of the imprinting ink are given below. 50 mg capsule contains shellac, propylene glycol and red iron oxide. 100 mg capsule contains shellac, propylene glycol and FD & C Blue No. # 2 aluminum lake. 200 mg capsule contains shellac, propylene glycol and yellow iron oxide. 400 mg capsule contains shellac, propylene glycol, titanium dioxide, yellow iron oxide and FD & C Blue No. # 2 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>55154-0161-0</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BAG (55154-0161-0) / 1 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55154-0161-00</NDC11Code>
<ProductNDC>55154-0161</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mycophenolate Mofetil</ProprietaryName>
<NonProprietaryName>Mycophenolate Mofetil</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260914</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200197</ApplicationNumber>
<LabelerName>Cardinal Health 107, LLC</LabelerName>
<SubstanceName>MYCOPHENOLATE MOFETIL</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimetabolite Immunosuppressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260914</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.</IndicationAndUsage>
<Description>Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C 23H 31NO 7, a molecular weight of 433.50, and the following structural formula:. Mycophenolate mofetil is a white to off-white crystalline powder. It is slightly soluble in water (43 mcg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. Mycophenolate mofetil is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of mycophenolate mofetil. Inactive ingredients in Mycophenolate mofetil capsules USP 250 mg include croscarmellose sodium, pregelatinized starch, povidone (K-90), isopropyl alcohol and magnesium stearate. The capsule shells contain gelatin, sodium lauryl sulphate, FD&C blue 2, red iron oxide, yellow iron oxide and titanium dioxide. The capsule is printed with edible black ink comprised of black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, strong ammonia solution. Inactive ingredients in mycophenolate mofetil tablets USP 500 mg include croscarmellose sodium, povidone (K-90), isopropyl alcohol, microcrystalline cellulose, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, red iron oxide, black iron oxide, and yellow iron oxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>55154-0180-0</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BAG (55154-0180-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55154-0180-00</NDC11Code>
<ProductNDC>55154-0180</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250519</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078040</ApplicationNumber>
<LabelerName>Cardinal Health 107, LLC</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250519</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone is an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
<Description>Risperidone Tablets contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone, USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Each risperidone tablet intended for oral administration contains 0.25 mg or 0.5 mg or 1 mg or 2 mg or 3 mg or 4 mg of risperidone. Additionally each tablet also contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium lauryl sulfate, and titanium dioxide. Additionally each 0.25 mg tablet contains iron oxide red and iron oxide yellow, 0.5 mg tablet contains iron oxide red, 2 mg tablet contains FD&C yellow # 6/sunset yellow FCF aluminum lake, 3 mg tablet contains D&C yellow # 10 aluminum lake and 4 mg tablet contains D&C yellow # 10 aluminum lake and FD&C blue # 2/ indigo carmine aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>55154-0181-0</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BAG (55154-0181-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55154-0181-00</NDC11Code>
<ProductNDC>55154-0181</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250506</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209603</ApplicationNumber>
<LabelerName>Cardinal Health 107, LLC</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Labetalol HCl tablets are indicated in the management of hypertension. Labetalol HCl tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
<Description>Labetalol Hydrochloride Tablets, USP are adrenergic receptor blocking agents that have both selective alpha1-adrenergic and non-selective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl), USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl) amino] ethyl] benzamide monohydrochloride and it has the following structural formula. Labetalol HCl, USP has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl, USP is a white to off-white crystalline powder, soluble in water. Each tablet, for oral administration, contains 100 mg, 200 mg, 300 mg or 400 mg of labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55154-0182-0</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BAG (55154-0182-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55154-0182-00</NDC11Code>
<ProductNDC>55154-0182</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250506</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209603</ApplicationNumber>
<LabelerName>Cardinal Health 107, LLC</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Labetalol HCl tablets are indicated in the management of hypertension. Labetalol HCl tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
<Description>Labetalol Hydrochloride Tablets, USP are adrenergic receptor blocking agents that have both selective alpha1-adrenergic and non-selective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl), USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl) amino] ethyl] benzamide monohydrochloride and it has the following structural formula. Labetalol HCl, USP has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl, USP is a white to off-white crystalline powder, soluble in water. Each tablet, for oral administration, contains 100 mg, 200 mg, 300 mg or 400 mg of labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55154-0183-0</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BAG (55154-0183-0) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55154-0183-00</NDC11Code>
<ProductNDC>55154-0183</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Sr</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250609</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202304</ApplicationNumber>
<LabelerName>Cardinal Health 107, LLC</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release (SR) tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)]. The efficacy of bupropion hydrochloride extended-release (SR) tablets in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Bupropion hydrochloride extended-release (SR) tablets, USP an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNO∙HCl. Bupropion hydrochloride, USP powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release (SR) tablets, USP are supplied for oral administration as 100-mg (blue), 150-mg (purple), and 200-mg (pink), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. In addition, the 100-mg tablet contains FD&C Blue #2/Indigo Carmine Aluminum Lake, the 150-mg tablet contains FD&C Blue #2/Indigo Carmine Aluminum Lake and FD&C Red #40/Allura Red Ac Aluminum Lake, and the 200-mg tablet contains ferrosoferric oxide and iron oxide red. Meet USP Dissolution Test 7.</Description>
</NDC>
<NDC>
<NDCCode>55154-0184-0</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BAG (55154-0184-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55154-0184-00</NDC11Code>
<ProductNDC>55154-0184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250506</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209603</ApplicationNumber>
<LabelerName>Cardinal Health 107, LLC</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Labetalol HCl tablets are indicated in the management of hypertension. Labetalol HCl tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
<Description>Labetalol Hydrochloride Tablets, USP are adrenergic receptor blocking agents that have both selective alpha1-adrenergic and non-selective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl), USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl) amino] ethyl] benzamide monohydrochloride and it has the following structural formula. Labetalol HCl, USP has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl, USP is a white to off-white crystalline powder, soluble in water. Each tablet, for oral administration, contains 100 mg, 200 mg, 300 mg or 400 mg of labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55154-0186-0</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BAG (55154-0186-0) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55154-0186-00</NDC11Code>
<ProductNDC>55154-0186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250709</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040858</ApplicationNumber>
<LabelerName>Cardinal Health 107, LLC</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain magnesium stearate, microcrystalline cellulose, orange lake blend, silicon dioxide, and sodium starch glycolate. The orange lake blend consists of FD&C yellow #6.</Description>
</NDC>
<NDC>
<NDCCode>55154-0187-0</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BAG (55154-0187-0) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55154-0187-00</NDC11Code>
<ProductNDC>55154-0187</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250709</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040858</ApplicationNumber>
<LabelerName>Cardinal Health 107, LLC</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain magnesium stearate, microcrystalline cellulose, orange lake blend, silicon dioxide, and sodium starch glycolate. The orange lake blend consists of FD&C yellow #6.</Description>
</NDC>
<NDC>
<NDCCode>55154-0188-0</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BAG (55154-0188-0) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55154-0188-00</NDC11Code>
<ProductNDC>55154-0188</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loratadine</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250828</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076301</ApplicationNumber>
<LabelerName>Cardinal Health 107, LLC</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250828</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose , 2 itchy, watery eyes, 3 sneezing , 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55154-0189-0</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BAG (55154-0189-0) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55154-0189-00</NDC11Code>
<ProductNDC>55154-0189</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251009</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077901</ApplicationNumber>
<LabelerName>Cardinal Health 107, LLC</LabelerName>
<SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets, USP may be employed alone or concomitantly with other antihypertensive agents.</IndicationAndUsage>
</NDC>
</NDCList>