{
"NDC": [
{
"NDCCode": "62032-539-07",
"PackageDescription": "1 KIT in 1 CARTON (62032-539-07) * 57 g in 1 BOTTLE, PLASTIC * 57 g in 1 BOTTLE, PLASTIC * 48 g in 1 BOTTLE, PLASTIC * 85 g in 1 TUBE * 57 g in 1 BOTTLE, PLASTIC * 198 mL in 1 BOTTLE, PLASTIC * 198 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "62032-0539-07",
"ProductNDC": "62032-539",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Obagi Nu-derm Fx System Normal - Dry",
"ProprietaryNameSuffix": "Skin Transformation Complexion Brightening System",
"NonProprietaryName": "Homosalate, Octisalate, And Zinc Oxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20191202",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Obagi Cosmeceuticals LLC",
"Status": "Active",
"LastUpdate": "2025-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191202",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "37808-539-07",
"PackageDescription": "6 POWDER, FOR SOLUTION in 1 CARTON (37808-539-07)",
"NDC11Code": "37808-0539-07",
"ProductNDC": "37808-539",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Heb Daytime Flu And Severe Cold And Cough",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20130628",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "HEB",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "650; 20; 10",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "temporarily relieves these symptoms due to a cold:minor aches and painsminor sore throat painheadachenasal and sinus congestioncough due to minor throat and bronchial irritation. temporarily reduces fever."
},
{
"NDCCode": "52959-539-07",
"PackageDescription": "7 CAPSULE in 1 BOTTLE (52959-539-07)",
"NDC11Code": "52959-0539-07",
"ProductNDC": "52959-539",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celebrex",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19981002",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020998",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of CELEBREX and other treatment options before deciding to use CELEBREX. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].",
"Description": "CELEBREX (celecoxib) is chemically designated as 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C17H14F3N3O2S, and the molecular weight is 381.38; the chemical structure is as follows. CELEBREX oral capsules contain either 50 mg, 100 mg, 200 mg or 400 mg of celecoxib, together with inactive ingredients including: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate."
},
{
"NDCCode": "67877-539-07",
"PackageDescription": "5 CAPSULE in 1 BOTTLE (67877-539-07) ",
"NDC11Code": "67877-0539-07",
"ProductNDC": "67877-539",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temozolomide",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170428",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207658",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170428",
"SamplePackage": "N",
"IndicationAndUsage": "TEMOZOLOMIDE Capsules, USP are an alkylating drug indicated for the treatment of adult patients with: Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1) Refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. (1.2).",
"Description": "Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide is. The material is a white to light tan/light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence TEMOZOLOMIDE can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. TEMOZOLOMIDE Capsules, USP:. Each capsule for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients for TEMOZOLOMIDE Capsules, USP are as follows. · TEMOZOLOMIDE 5 mg: lactose anhydrous (132.8 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (7.5 mg), tartaric acid (1.5 mg), and stearic acid (3.0 mg). ·TEMOZOLOMIDE 20 mg: lactose anhydrous (182.2 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (11 mg), tartaric acid (2.2 mg), and stearic acid (4.4 mg). ·TEMOZOLOMIDE 100 mg: lactose anhydrous (175.7 mg), colloidal silicon dioxide (0.3 mg), sodium starch glycolate (15 mg), tartaric acid (3.0 mg), and stearic acid (6.0 mg). ·TEMOZOLOMIDE 140 mg: lactose anhydrous (246 mg), colloidal silicon dioxide (0.4 mg), sodium starch glycolate (21 mg), tartaric acid (4.2 mg), and stearic acid (8.4 mg). ·TEMOZOLOMIDE 180 mg: lactose anhydrous (316.3 mg), colloidal silicon dioxide (0.5 mg), sodium starch glycolate (27 mg), tartaric acid (5.4 mg), and stearic acid (10.8 mg). · TEMOZOLOMIDE 250 mg: lactose anhydrous (154.3 mg), colloidal silicon dioxide (0.7 mg), sodium starch glycolate (22.5 mg), tartaric acid (9.0 mg), and stearic acid (13.5 mg). The body of the capsules is made of gelatin and titanium dioxide and is opaque white. The cap is also made of gelatin and the colors may vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide, and ferric oxide. · TEMOZOLOMIDE 5 mg: The opaque green cap contains gelatin, titanium dioxide, iron oxide yellow and FD&C Blue 2. ·TEMOZOLOMIDE 20 mg: The opaque yellow cap contains gelatin, titanium dioxide and iron oxide yellow. ·TEMOZOLOMIDE 100 mg: The opaque flesh cap contains gelatin, titanium dioxide and iron oxide red. ·TEMOZOLOMIDE 140 mg: The transparent blue cap contains gelatin, FD&C Blue #2, and titanium dioxide. · TEMOZOLOMIDE 180 mg: The opaque orange cap contains gelatin, titanium dioxide and iron oxide red. ·TEMOZOLOMIDE 250 mg: The opaque white cap contains gelatin and titanium dioxide."
},
{
"NDCCode": "71919-539-07",
"PackageDescription": "15 mL in 1 VIAL, GLASS (71919-539-07) ",
"NDC11Code": "71919-0539-07",
"ProductNDC": "71919-539",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Piper Methysticum",
"NonProprietaryName": "Macropiper Methysticum Root",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20090130",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "MACROPIPER METHYSTICUM ROOT",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20090130",
"SamplePackage": "N"
},
{
"NDCCode": "62032-002-07",
"PackageDescription": "50 mL in 1 BOTTLE (62032-002-07) ",
"NDC11Code": "62032-0002-07",
"ProductNDC": "62032-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sun Shield Mineral Uv Barrier Protect Broad Spectrum Spf 40 Sunscreen",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260428",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Obagi Cosmeceuticals LLC",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "9.4",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260428",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "62032-003-07",
"PackageDescription": "59 mL in 1 BOTTLE, DISPENSING (62032-003-07) ",
"NDC11Code": "62032-0003-07",
"ProductNDC": "62032-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Obagi Medical Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200615",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "OBAGI COSMECEUTICALS LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "65",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200615",
"SamplePackage": "N",
"IndicationAndUsage": "helps decrease bacteria on the hands."
},
{
"NDCCode": "62032-129-07",
"PackageDescription": "1000 mL in 1 BOTTLE, PUMP (62032-129-07)",
"NDC11Code": "62032-0129-07",
"ProductNDC": "62032-129",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daily Care Foaming Cleanser",
"ProprietaryNameSuffix": "Acne Treatment",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130118",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "OMP, INC.",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "for the treatment of acne. dries up acne pimples. helps prevent new acne pimples."
},
{
"NDCCode": "62032-527-07",
"PackageDescription": "1 KIT in 1 CARTON (62032-527-07) * 85 g in 1 TUBE",
"NDC11Code": "62032-0527-07",
"ProductNDC": "62032-527",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Obagi Nu-derm Fx System - Normal To Dry",
"NonProprietaryName": "Octinoxate, Zinc Oxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20151104",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "OMP, Inc.",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "62032-528-07",
"PackageDescription": "1 KIT in 1 CARTON (62032-528-07) * 57 g in 1 BOTTLE, PLASTIC * 28 g in 1 BOTTLE, PLASTIC * 28 g in 1 TUBE",
"NDC11Code": "62032-0528-07",
"ProductNDC": "62032-528",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Obagi Medical - Nu-derm System - Normal To Dry - Skin Transformation Trial Kit",
"NonProprietaryName": "Octinoxate, Zinc Oxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20151116",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Obagi Cosmeceuticals LLC",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20151116",
"SamplePackage": "N"
},
{
"NDCCode": "62032-532-07",
"PackageDescription": "1 KIT in 1 CARTON (62032-532-07) * 59 mL in 1 BOTTLE, PLASTIC * 57 g in 1 BOTTLE, PLASTIC * 28 g in 1 BOTTLE, PLASTIC * 85 g in 1 TUBE * 59 mL in 1 BOTTLE, PLASTIC * 28 g in 1 BOTTLE, PLASTIC",
"NDC11Code": "62032-0532-07",
"ProductNDC": "62032-532",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nu-derm System Normal-dry",
"ProprietaryNameSuffix": "Skin Transformation Trial",
"NonProprietaryName": "Hydroquinone, Homosalate, Octisalate, And Zinc Oxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20191202",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "OBAGI COSMECEUTICAL LLC",
"Status": "Active",
"LastUpdate": "2025-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191202",
"SamplePackage": "N",
"Description": "Hydroquinone, USP 4% is 1, 4-benzenediol. The drug is freely soluble in water and in alcohol. Chemically, hydroquinone is designated as p-dihydroxybenzene; the empirical formula is C6H6O2; molecular weight is 110.11 g/mol. The chemical structure is in the diagram below."
},
{
"NDCCode": "62032-907-07",
"PackageDescription": "1 KIT in 1 BOX (62032-907-07) * 1 BOTTLE, DROPPER in 1 CARTON / 30 mL in 1 BOTTLE, DROPPER * 1 BOTTLE, PUMP in 1 CARTON / 30 mL in 1 BOTTLE, PUMP * 1 TUBE in 1 CARTON (62032-050-54) / 48 g in 1 TUBE * 59 mL in 1 BOTTLE, PLASTIC * 60 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "62032-0907-07",
"ProductNDC": "62032-907",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Obagi Skintrinsiq Antioxidant Protocol",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "KIT",
"StartMarketingDate": "20210801",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Obagi Cosmeceuticals LLC",
"Status": "Deprecated",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210801",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "62032-106-10",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62032-106-10) / 30 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62032-0106-10",
"ProductNDC": "62032-106",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Obagi C Rx System C Clarifying Serum",
"NonProprietaryName": "Hydroquinone",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Obagi Cosmeceuticals LLC",
"SubstanceName": "HYDROQUINONE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Depigmenting Activity [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100101",
"SamplePackage": "N",
"IndicationAndUsage": "The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.",
"Description": "Hydroquinone is 1,4-benzenediol. Hydroquinone occurs as fine, white needles. The drug is freely soluble in water and in alcohol. Chemically, hydroquinone is designated as p-dihydroxybenzene; the empirical formula is C6H6O2; molecular weight is 110.11 g per mol. The chemical structure is in the diagram."
},
{
"NDCCode": "62032-536-57",
"PackageDescription": "1 KIT in 1 CARTON (62032-536-57) * 85 g in 1 TUBE (62032-142-11) * 177 mL in 1 BOTTLE, PLASTIC * 198 mL in 1 BOTTLE, PLASTIC * 57 g in 1 BOTTLE, PLASTIC * 1 BOTTLE, GLASS in 1 CARTON > 30 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62032-0536-57",
"ProductNDC": "62032-536",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Obagi-c Fx System Normal-oily",
"ProprietaryNameSuffix": "Skin Brightening System With Arbutin",
"NonProprietaryName": "Homosalate, Octisalate, And Zinc Oxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20191202",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Obagi Cosmeceuticals LLC",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20191202",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "62032-537-58",
"PackageDescription": "1 KIT in 1 CARTON (62032-537-58) * 57 g in 1 BOTTLE, PLASTIC * 85 g in 1 TUBE * 177 mL in 1 BOTTLE, PLASTIC * 1 BOTTLE, GLASS in 1 CARTON > 30 mL in 1 BOTTLE, GLASS * 57 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "62032-0537-58",
"ProductNDC": "62032-537",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Obagi-c Fx System Normal-dry",
"ProprietaryNameSuffix": "Skin Brightening System With Arbutin",
"NonProprietaryName": "Homosalate, Octisalate, And Zinc Oxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20191202",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Obagi Cosmeceuticals LLC",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20191202",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "0409-3383-02",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (0409-3383-02) / 10 mL in 1 VIAL, SINGLE-USE (0409-3383-11) ",
"NDC11Code": "00409-3383-02",
"ProductNDC": "0409-3383",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Piperacillin And Tazobactam",
"NonProprietaryName": "Piperacillin And Tazobactam",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS; PARENTERAL",
"StartMarketingDate": "20101021",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065362",
"LabelerName": "Hospira, Inc",
"SubstanceName": "PIPERACILLIN SODIUM; TAZOBACTAM SODIUM",
"StrengthNumber": "2; .25",
"StrengthUnit": "g/10mL; g/10mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101021",
"EndMarketingDatePackage": "20261231",
"SamplePackage": "N",
"IndicationAndUsage": "Piperacillin and tazobactam for injection is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1), 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2), 3 Skin and skin structure infections in adults (1.3), 4 Female pelvic infections in adults (1.4), 5 Community-acquired pneumonia in adults (1.5).",
"Description": "Piperacillin and tazobactam for injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine‑carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2‑carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1‑azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is. Piperacillin and tazobactam for injection, USP, is a white to yellowish sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. The product does not contain excipients or preservatives. Dilute solutions are colorless to yellowish. Each piperacillin and tazobactam for injection, USP 2.25 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains 4.69 mEq (108 mg) of sodium. Each piperacillin and tazobactam for injection, USP 3.375 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 7.04 mEq (162 mg) of sodium. Each piperacillin and tazobactam for injection, USP 4.5 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each vial contains 9.39 mEq (216 mg) of sodium. Piperacillin and tazobactam for injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Meets USP Organic Impurities Procedure 3."
},
{
"NDCCode": "0409-3383-10",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (0409-3383-10) / 10 mL in 1 VIAL, SINGLE-USE (0409-3383-11) ",
"NDC11Code": "00409-3383-10",
"ProductNDC": "0409-3383",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Piperacillin And Tazobactam",
"NonProprietaryName": "Piperacillin And Tazobactam",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS; PARENTERAL",
"StartMarketingDate": "20101021",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065362",
"LabelerName": "Hospira, Inc",
"SubstanceName": "PIPERACILLIN SODIUM; TAZOBACTAM SODIUM",
"StrengthNumber": "2; .25",
"StrengthUnit": "g/10mL; g/10mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250609",
"SamplePackage": "N",
"IndicationAndUsage": "Piperacillin and tazobactam for injection is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1), 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2), 3 Skin and skin structure infections in adults (1.3), 4 Female pelvic infections in adults (1.4), 5 Community-acquired pneumonia in adults (1.5).",
"Description": "Piperacillin and tazobactam for injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine‑carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2‑carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1‑azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is. Piperacillin and tazobactam for injection, USP, is a white to yellowish sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. The product does not contain excipients or preservatives. Dilute solutions are colorless to yellowish. Each piperacillin and tazobactam for injection, USP 2.25 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains 4.69 mEq (108 mg) of sodium. Each piperacillin and tazobactam for injection, USP 3.375 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 7.04 mEq (162 mg) of sodium. Each piperacillin and tazobactam for injection, USP 4.5 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each vial contains 9.39 mEq (216 mg) of sodium. Piperacillin and tazobactam for injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Meets USP Organic Impurities Procedure 3."
},
{
"NDCCode": "0409-3385-15",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (0409-3385-15) / 15 mL in 1 VIAL, SINGLE-USE (0409-3385-11) ",
"NDC11Code": "00409-3385-15",
"ProductNDC": "0409-3385",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Piperacillin And Tazobactam",
"NonProprietaryName": "Piperacillin And Tazobactam",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS; PARENTERAL",
"StartMarketingDate": "20101021",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065362",
"LabelerName": "Hospira, Inc",
"SubstanceName": "PIPERACILLIN SODIUM; TAZOBACTAM SODIUM",
"StrengthNumber": "3; .375",
"StrengthUnit": "g/15mL; g/15mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250609",
"SamplePackage": "N",
"IndicationAndUsage": "Piperacillin and tazobactam for injection is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1), 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2), 3 Skin and skin structure infections in adults (1.3), 4 Female pelvic infections in adults (1.4), 5 Community-acquired pneumonia in adults (1.5).",
"Description": "Piperacillin and tazobactam for injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine‑carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2‑carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1‑azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is. Piperacillin and tazobactam for injection, USP, is a white to yellowish sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. The product does not contain excipients or preservatives. Dilute solutions are colorless to yellowish. Each piperacillin and tazobactam for injection, USP 2.25 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains 4.69 mEq (108 mg) of sodium. Each piperacillin and tazobactam for injection, USP 3.375 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 7.04 mEq (162 mg) of sodium. Each piperacillin and tazobactam for injection, USP 4.5 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each vial contains 9.39 mEq (216 mg) of sodium. Piperacillin and tazobactam for injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Meets USP Organic Impurities Procedure 3."
},
{
"NDCCode": "0409-3390-10",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (0409-3390-10) / 20 mL in 1 VIAL, SINGLE-USE (0409-3390-11) ",
"NDC11Code": "00409-3390-10",
"ProductNDC": "0409-3390",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Piperacillin And Tazobactam",
"NonProprietaryName": "Piperacillin And Tazobactam",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS; PARENTERAL",
"StartMarketingDate": "20101021",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065362",
"LabelerName": "Hospira, Inc",
"SubstanceName": "PIPERACILLIN SODIUM; TAZOBACTAM SODIUM",
"StrengthNumber": "4; .5",
"StrengthUnit": "g/20mL; g/20mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250609",
"SamplePackage": "N",
"IndicationAndUsage": "Piperacillin and tazobactam for injection is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1), 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2), 3 Skin and skin structure infections in adults (1.3), 4 Female pelvic infections in adults (1.4), 5 Community-acquired pneumonia in adults (1.5).",
"Description": "Piperacillin and tazobactam for injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine‑carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2‑carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1‑azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is. Piperacillin and tazobactam for injection, USP, is a white to yellowish sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. The product does not contain excipients or preservatives. Dilute solutions are colorless to yellowish. Each piperacillin and tazobactam for injection, USP 2.25 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains 4.69 mEq (108 mg) of sodium. Each piperacillin and tazobactam for injection, USP 3.375 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 7.04 mEq (162 mg) of sodium. Each piperacillin and tazobactam for injection, USP 4.5 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each vial contains 9.39 mEq (216 mg) of sodium. Piperacillin and tazobactam for injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Meets USP Organic Impurities Procedure 3."
},
{
"NDCCode": "0781-3110-95",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (0781-3110-95) / 10 mL in 1 VIAL, SINGLE-USE (0781-3110-90) ",
"NDC11Code": "00781-3110-95",
"ProductNDC": "0781-3110",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Piperacillin And Tazobactam",
"NonProprietaryName": "Piperacillin And Tazobactam",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS; PARENTERAL",
"StartMarketingDate": "20101021",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065362",
"LabelerName": "Sandoz Inc",
"SubstanceName": "PIPERACILLIN SODIUM; TAZOBACTAM SODIUM",
"StrengthNumber": "2; .25",
"StrengthUnit": "g/10mL; g/10mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101021",
"SamplePackage": "N",
"IndicationAndUsage": "Piperacillin and tazobactam for injection is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1), 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2), 3 Skin and skin structure infections in adults (1.3), 4 Female pelvic infections in adults (1.4), 5 Community-acquired pneumonia in adults (1.5).",
"Description": "Piperacillin and tazobactam for injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine‑carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2‑carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1‑azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is. Piperacillin and tazobactam for injection, USP, is a white to yellowish sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. The product does not contain excipients or preservatives. Dilute solutions are colorless to yellowish. Each piperacillin and tazobactam for injection, USP 2.25 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains 4.69 mEq (108 mg) of sodium. Each piperacillin and tazobactam for injection, USP 3.375 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 7.04 mEq (162 mg) of sodium. Each piperacillin and tazobactam for injection, USP 4.5 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each vial contains 9.39 mEq (216 mg) of sodium. Piperacillin and tazobactam for injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Meets USP Organic Impurities Procedure 3."
},
{
"NDCCode": "0781-3113-95",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (0781-3113-95) / 15 mL in 1 VIAL, SINGLE-USE (0781-3113-90) ",
"NDC11Code": "00781-3113-95",
"ProductNDC": "0781-3113",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Piperacillin And Tazobactam",
"NonProprietaryName": "Piperacillin And Tazobactam",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS; PARENTERAL",
"StartMarketingDate": "20101021",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065362",
"LabelerName": "Sandoz Inc",
"SubstanceName": "PIPERACILLIN SODIUM; TAZOBACTAM SODIUM",
"StrengthNumber": "3; .375",
"StrengthUnit": "g/15mL; g/15mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101021",
"SamplePackage": "N",
"IndicationAndUsage": "Piperacillin and tazobactam for injection is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1), 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2), 3 Skin and skin structure infections in adults (1.3), 4 Female pelvic infections in adults (1.4), 5 Community-acquired pneumonia in adults (1.5).",
"Description": "Piperacillin and tazobactam for injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine‑carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2‑carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1‑azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is. Piperacillin and tazobactam for injection, USP, is a white to yellowish sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. The product does not contain excipients or preservatives. Dilute solutions are colorless to yellowish. Each piperacillin and tazobactam for injection, USP 2.25 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains 4.69 mEq (108 mg) of sodium. Each piperacillin and tazobactam for injection, USP 3.375 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 7.04 mEq (162 mg) of sodium. Each piperacillin and tazobactam for injection, USP 4.5 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each vial contains 9.39 mEq (216 mg) of sodium. Piperacillin and tazobactam for injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Meets USP Organic Impurities Procedure 3."
},
{
"NDCCode": "0781-3114-95",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (0781-3114-95) / 20 mL in 1 VIAL, SINGLE-USE (0781-3114-91) ",
"NDC11Code": "00781-3114-95",
"ProductNDC": "0781-3114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Piperacillin And Tazobactam",
"NonProprietaryName": "Piperacillin And Tazobactam",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS; PARENTERAL",
"StartMarketingDate": "20101021",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065362",
"LabelerName": "Sandoz Inc",
"SubstanceName": "PIPERACILLIN SODIUM; TAZOBACTAM SODIUM",
"StrengthNumber": "4; .5",
"StrengthUnit": "g/20mL; g/20mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101021",
"SamplePackage": "N",
"IndicationAndUsage": "Piperacillin and tazobactam for injection is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1), 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2), 3 Skin and skin structure infections in adults (1.3), 4 Female pelvic infections in adults (1.4), 5 Community-acquired pneumonia in adults (1.5).",
"Description": "Piperacillin and tazobactam for injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine‑carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2‑carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1‑azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is. Piperacillin and tazobactam for injection, USP, is a white to yellowish sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. The product does not contain excipients or preservatives. Dilute solutions are colorless to yellowish. Each piperacillin and tazobactam for injection, USP 2.25 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains 4.69 mEq (108 mg) of sodium. Each piperacillin and tazobactam for injection, USP 3.375 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 7.04 mEq (162 mg) of sodium. Each piperacillin and tazobactam for injection, USP 4.5 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each vial contains 9.39 mEq (216 mg) of sodium. Piperacillin and tazobactam for injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Meets USP Organic Impurities Procedure 3."
},
{
"NDCCode": "13668-539-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (13668-539-05) ",
"NDC11Code": "13668-0539-05",
"ProductNDC": "13668-539",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eslicarbazepine Acetate",
"NonProprietaryName": "Eslicarbazepine Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250506",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211227",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "ESLICARBAZEPINE ACETATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250506",
"SamplePackage": "N",
"IndicationAndUsage": "Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.",
"Description": "The chemical name of eslicarbazepine acetate, USP is (S)-10-Acetoxy-10,11-dihydro-5H dibenz[b,f]azepine-5-carboxamide. Eslicarbazepine acetate, USP is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C 17H 16N 2O 3and its molecular weight is 296.32. The chemical structure is:. Eslicarbazepine acetate, USP is a white to almost white crystalline Powder. It is Freely soluble in Dimethylsulphoxide and Dichloromethane. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate, USP and the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and povidone (K-30)."
},
{
"NDCCode": "13668-539-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (13668-539-30) ",
"NDC11Code": "13668-0539-30",
"ProductNDC": "13668-539",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eslicarbazepine Acetate",
"NonProprietaryName": "Eslicarbazepine Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250506",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211227",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "ESLICARBAZEPINE ACETATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250506",
"SamplePackage": "N",
"IndicationAndUsage": "Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.",
"Description": "The chemical name of eslicarbazepine acetate, USP is (S)-10-Acetoxy-10,11-dihydro-5H dibenz[b,f]azepine-5-carboxamide. Eslicarbazepine acetate, USP is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C 17H 16N 2O 3and its molecular weight is 296.32. The chemical structure is:. Eslicarbazepine acetate, USP is a white to almost white crystalline Powder. It is Freely soluble in Dimethylsulphoxide and Dichloromethane. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate, USP and the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and povidone (K-30)."
},
{
"NDCCode": "13668-539-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (13668-539-60) ",
"NDC11Code": "13668-0539-60",
"ProductNDC": "13668-539",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eslicarbazepine Acetate",
"NonProprietaryName": "Eslicarbazepine Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250506",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211227",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "ESLICARBAZEPINE ACETATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250506",
"SamplePackage": "N",
"IndicationAndUsage": "Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.",
"Description": "The chemical name of eslicarbazepine acetate, USP is (S)-10-Acetoxy-10,11-dihydro-5H dibenz[b,f]azepine-5-carboxamide. Eslicarbazepine acetate, USP is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C 17H 16N 2O 3and its molecular weight is 296.32. The chemical structure is:. Eslicarbazepine acetate, USP is a white to almost white crystalline Powder. It is Freely soluble in Dimethylsulphoxide and Dichloromethane. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate, USP and the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and povidone (K-30)."
},
{
"NDCCode": "16590-030-25",
"PackageDescription": "180 SPRAY, SUSPENSION in 1 BOTTLE, PUMP (16590-030-25)",
"NDC11Code": "16590-0030-25",
"ProductNDC": "16590-030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Beconase",
"ProprietaryNameSuffix": "Aq",
"NonProprietaryName": "Beclomethasone Dipropionate Monohydrate",
"DosageFormName": "SPRAY, SUSPENSION",
"RouteName": "NASAL",
"StartMarketingDate": "19891001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019389",
"LabelerName": "Stat Rx USA LLC",
"SubstanceName": "BECLOMETHASONE DIPROPIONATE MONOHYDRATE",
"StrengthNumber": "42",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "BECONASE AQ Nasal Spray is indicated for the relief of the symptoms of seasonal or perennial allergic and nonallergic (vasomotor) rhinitis. Results from 2 clinical trials have shown that significant symptomatic relief was obtained within 3 days. However, symptomatic relief may not occur in some patients for as long as 2 weeks. BECONASE AQ Nasal Spray should not be continued beyond 3 weeks in the absence of significant symptomatic improvement. BECONASE AQ Nasal Spray should not be used in the presence of untreated localized infection involving the nasal mucosa. BECONASE AQ Nasal Spray is also indicated for the prevention of recurrence of nasal polyps following surgical removal. Clinical studies have shown that treatment of the symptoms associated with nasal polyps may have to be continued for several weeks or more before a therapeutic result can be fully assessed. Recurrence of symptoms due to polyps can occur after stopping treatment, depending on the severity of the disease.",
"Description": "Beclomethasone dipropionate, monohydrate, the active component of BECONASE AQ Nasal Spray, is an anti-inflammatory steroid having the chemical name 9-chloro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, monohydrate and the following chemical structure. Beclomethasone 17,21-dipropionate is a diester of beclomethasone, a synthetic halogenated corticosteroid. Beclomethasone dipropionate, monohydrate is a white to creamy-white, odorless powder with a molecular weight of 539.06. It is very slightly soluble in water, very soluble in chloroform, and freely soluble in acetone and in ethanol. BECONASE AQ Nasal Spray is a metered-dose, manual pump spray unit containing a microcrystalline suspension of beclomethasone dipropionate, monohydrate equivalent to 42 mcg of beclomethasone dipropionate, calculated on the dried basis, in an aqueous medium containing microcrystalline cellulose, carboxymethylcellulose sodium, dextrose, benzalkonium chloride, polysorbate 80, and 0.25% v/w phenylethyl alcohol. The pH through expiry is 5.0 to 6.8. After initial priming (6 actuations), each actuation of the pump delivers from the nasal adapter 100 mg of suspension containing beclomethasone dipropionate, monohydrate equivalent to 42 mcg of beclomethasone dipropionate. If the pump is not used for 7 days, it should be primed until a fine spray appears. Each 25-g bottle of BECONASE AQ Nasal Spray provides 180 metered sprays."
},
{
"NDCCode": "16590-539-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (16590-539-30)",
"NDC11Code": "16590-0539-30",
"ProductNDC": "16590-539",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zonisamide",
"NonProprietaryName": "Zonisamide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077634",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "ZONISAMIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.",
"Description": "Zonisamide is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The molecular formula is C8H8N2O3S with a molecular weight of 212.23. Zonisamide is a white powder, pKa = 10.2, and is moderately soluble in water (0.8 mg/mL) and 0.1 N HCl (0.5 mg/mL). The chemical structure is. Zonisamide is supplied for oral administration as capsules containing 25 mg, 50 mg or 100 mg zonisamide. Each capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, gelatin, and titanium dioxide. In addition, individual empty hard gelatin capsule shell contains:50 mg: Black iron oxide.100 mg: FD and C Blue #1 and FD and C Red #40. The imprinting ink contains black iron oxide, shellac glaze, propylene glycol and also contains either FD and C Blue No. 2, FD and C Red No. 40, FD and C Blue No. 1 and D and C Yellow No.10 or strong ammonia solution and potassium hydroxide."
},
{
"NDCCode": "16590-539-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (16590-539-60)",
"NDC11Code": "16590-0539-60",
"ProductNDC": "16590-539",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zonisamide",
"NonProprietaryName": "Zonisamide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077634",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "ZONISAMIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.",
"Description": "Zonisamide is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The molecular formula is C8H8N2O3S with a molecular weight of 212.23. Zonisamide is a white powder, pKa = 10.2, and is moderately soluble in water (0.8 mg/mL) and 0.1 N HCl (0.5 mg/mL). The chemical structure is. Zonisamide is supplied for oral administration as capsules containing 25 mg, 50 mg or 100 mg zonisamide. Each capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, gelatin, and titanium dioxide. In addition, individual empty hard gelatin capsule shell contains:50 mg: Black iron oxide.100 mg: FD and C Blue #1 and FD and C Red #40. The imprinting ink contains black iron oxide, shellac glaze, propylene glycol and also contains either FD and C Blue No. 2, FD and C Red No. 40, FD and C Blue No. 1 and D and C Yellow No.10 or strong ammonia solution and potassium hydroxide."
},
{
"NDCCode": "16590-539-82",
"PackageDescription": "180 CAPSULE in 1 BOTTLE (16590-539-82)",
"NDC11Code": "16590-0539-82",
"ProductNDC": "16590-539",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zonisamide",
"NonProprietaryName": "Zonisamide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077634",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "ZONISAMIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.",
"Description": "Zonisamide is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The molecular formula is C8H8N2O3S with a molecular weight of 212.23. Zonisamide is a white powder, pKa = 10.2, and is moderately soluble in water (0.8 mg/mL) and 0.1 N HCl (0.5 mg/mL). The chemical structure is. Zonisamide is supplied for oral administration as capsules containing 25 mg, 50 mg or 100 mg zonisamide. Each capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, gelatin, and titanium dioxide. In addition, individual empty hard gelatin capsule shell contains:50 mg: Black iron oxide.100 mg: FD and C Blue #1 and FD and C Red #40. The imprinting ink contains black iron oxide, shellac glaze, propylene glycol and also contains either FD and C Blue No. 2, FD and C Red No. 40, FD and C Blue No. 1 and D and C Yellow No.10 or strong ammonia solution and potassium hydroxide."
},
{
"NDCCode": "16590-539-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (16590-539-90)",
"NDC11Code": "16590-0539-90",
"ProductNDC": "16590-539",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zonisamide",
"NonProprietaryName": "Zonisamide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077634",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "ZONISAMIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.",
"Description": "Zonisamide is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The molecular formula is C8H8N2O3S with a molecular weight of 212.23. Zonisamide is a white powder, pKa = 10.2, and is moderately soluble in water (0.8 mg/mL) and 0.1 N HCl (0.5 mg/mL). The chemical structure is. Zonisamide is supplied for oral administration as capsules containing 25 mg, 50 mg or 100 mg zonisamide. Each capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, gelatin, and titanium dioxide. In addition, individual empty hard gelatin capsule shell contains:50 mg: Black iron oxide.100 mg: FD and C Blue #1 and FD and C Red #40. The imprinting ink contains black iron oxide, shellac glaze, propylene glycol and also contains either FD and C Blue No. 2, FD and C Red No. 40, FD and C Blue No. 1 and D and C Yellow No.10 or strong ammonia solution and potassium hydroxide."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>62032-539-07</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (62032-539-07) * 57 g in 1 BOTTLE, PLASTIC * 57 g in 1 BOTTLE, PLASTIC * 48 g in 1 BOTTLE, PLASTIC * 85 g in 1 TUBE * 57 g in 1 BOTTLE, PLASTIC * 198 mL in 1 BOTTLE, PLASTIC * 198 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>62032-0539-07</NDC11Code>
<ProductNDC>62032-539</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Obagi Nu-derm Fx System Normal - Dry</ProprietaryName>
<ProprietaryNameSuffix>Skin Transformation Complexion Brightening System</ProprietaryNameSuffix>
<NonProprietaryName>Homosalate, Octisalate, And Zinc Oxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20191202</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Obagi Cosmeceuticals LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37808-539-07</NDCCode>
<PackageDescription>6 POWDER, FOR SOLUTION in 1 CARTON (37808-539-07)</PackageDescription>
<NDC11Code>37808-0539-07</NDC11Code>
<ProductNDC>37808-539</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Heb Daytime Flu And Severe Cold And Cough</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130628</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>HEB</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>650; 20; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>temporarily relieves these symptoms due to a cold:minor aches and painsminor sore throat painheadachenasal and sinus congestioncough due to minor throat and bronchial irritation. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52959-539-07</NDCCode>
<PackageDescription>7 CAPSULE in 1 BOTTLE (52959-539-07)</PackageDescription>
<NDC11Code>52959-0539-07</NDC11Code>
<ProductNDC>52959-539</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celebrex</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981002</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020998</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of CELEBREX and other treatment options before deciding to use CELEBREX. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].</IndicationAndUsage>
<Description>CELEBREX (celecoxib) is chemically designated as 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C17H14F3N3O2S, and the molecular weight is 381.38; the chemical structure is as follows. CELEBREX oral capsules contain either 50 mg, 100 mg, 200 mg or 400 mg of celecoxib, together with inactive ingredients including: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>67877-539-07</NDCCode>
<PackageDescription>5 CAPSULE in 1 BOTTLE (67877-539-07) </PackageDescription>
<NDC11Code>67877-0539-07</NDC11Code>
<ProductNDC>67877-539</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temozolomide</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170428</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207658</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TEMOZOLOMIDE Capsules, USP are an alkylating drug indicated for the treatment of adult patients with: Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1) Refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. (1.2).</IndicationAndUsage>
<Description>Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide is. The material is a white to light tan/light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence TEMOZOLOMIDE can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. TEMOZOLOMIDE Capsules, USP:. Each capsule for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients for TEMOZOLOMIDE Capsules, USP are as follows. · TEMOZOLOMIDE 5 mg: lactose anhydrous (132.8 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (7.5 mg), tartaric acid (1.5 mg), and stearic acid (3.0 mg). ·TEMOZOLOMIDE 20 mg: lactose anhydrous (182.2 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (11 mg), tartaric acid (2.2 mg), and stearic acid (4.4 mg). ·TEMOZOLOMIDE 100 mg: lactose anhydrous (175.7 mg), colloidal silicon dioxide (0.3 mg), sodium starch glycolate (15 mg), tartaric acid (3.0 mg), and stearic acid (6.0 mg). ·TEMOZOLOMIDE 140 mg: lactose anhydrous (246 mg), colloidal silicon dioxide (0.4 mg), sodium starch glycolate (21 mg), tartaric acid (4.2 mg), and stearic acid (8.4 mg). ·TEMOZOLOMIDE 180 mg: lactose anhydrous (316.3 mg), colloidal silicon dioxide (0.5 mg), sodium starch glycolate (27 mg), tartaric acid (5.4 mg), and stearic acid (10.8 mg). · TEMOZOLOMIDE 250 mg: lactose anhydrous (154.3 mg), colloidal silicon dioxide (0.7 mg), sodium starch glycolate (22.5 mg), tartaric acid (9.0 mg), and stearic acid (13.5 mg). The body of the capsules is made of gelatin and titanium dioxide and is opaque white. The cap is also made of gelatin and the colors may vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide, and ferric oxide. · TEMOZOLOMIDE 5 mg: The opaque green cap contains gelatin, titanium dioxide, iron oxide yellow and FD&C Blue 2. ·TEMOZOLOMIDE 20 mg: The opaque yellow cap contains gelatin, titanium dioxide and iron oxide yellow. ·TEMOZOLOMIDE 100 mg: The opaque flesh cap contains gelatin, titanium dioxide and iron oxide red. ·TEMOZOLOMIDE 140 mg: The transparent blue cap contains gelatin, FD&C Blue #2, and titanium dioxide. · TEMOZOLOMIDE 180 mg: The opaque orange cap contains gelatin, titanium dioxide and iron oxide red. ·TEMOZOLOMIDE 250 mg: The opaque white cap contains gelatin and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71919-539-07</NDCCode>
<PackageDescription>15 mL in 1 VIAL, GLASS (71919-539-07) </PackageDescription>
<NDC11Code>71919-0539-07</NDC11Code>
<ProductNDC>71919-539</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Piper Methysticum</ProprietaryName>
<NonProprietaryName>Macropiper Methysticum Root</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090130</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>MACROPIPER METHYSTICUM ROOT</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62032-002-07</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (62032-002-07) </PackageDescription>
<NDC11Code>62032-0002-07</NDC11Code>
<ProductNDC>62032-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sun Shield Mineral Uv Barrier Protect Broad Spectrum Spf 40 Sunscreen</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260428</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Obagi Cosmeceuticals LLC</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>9.4</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62032-003-07</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DISPENSING (62032-003-07) </PackageDescription>
<NDC11Code>62032-0003-07</NDC11Code>
<ProductNDC>62032-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Obagi Medical Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200615</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>OBAGI COSMECEUTICALS LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>65</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps decrease bacteria on the hands.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62032-129-07</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE, PUMP (62032-129-07)</PackageDescription>
<NDC11Code>62032-0129-07</NDC11Code>
<ProductNDC>62032-129</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Daily Care Foaming Cleanser</ProprietaryName>
<ProprietaryNameSuffix>Acne Treatment</ProprietaryNameSuffix>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130118</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>OMP, INC.</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for the treatment of acne. dries up acne pimples. helps prevent new acne pimples.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62032-527-07</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (62032-527-07) * 85 g in 1 TUBE</PackageDescription>
<NDC11Code>62032-0527-07</NDC11Code>
<ProductNDC>62032-527</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Obagi Nu-derm Fx System - Normal To Dry</ProprietaryName>
<NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20151104</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>OMP, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62032-528-07</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (62032-528-07) * 57 g in 1 BOTTLE, PLASTIC * 28 g in 1 BOTTLE, PLASTIC * 28 g in 1 TUBE</PackageDescription>
<NDC11Code>62032-0528-07</NDC11Code>
<ProductNDC>62032-528</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Obagi Medical - Nu-derm System - Normal To Dry - Skin Transformation Trial Kit</ProprietaryName>
<NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20151116</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Obagi Cosmeceuticals LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62032-532-07</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (62032-532-07) * 59 mL in 1 BOTTLE, PLASTIC * 57 g in 1 BOTTLE, PLASTIC * 28 g in 1 BOTTLE, PLASTIC * 85 g in 1 TUBE * 59 mL in 1 BOTTLE, PLASTIC * 28 g in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>62032-0532-07</NDC11Code>
<ProductNDC>62032-532</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nu-derm System Normal-dry</ProprietaryName>
<ProprietaryNameSuffix>Skin Transformation Trial</ProprietaryNameSuffix>
<NonProprietaryName>Hydroquinone, Homosalate, Octisalate, And Zinc Oxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20191202</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>OBAGI COSMECEUTICAL LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Hydroquinone, USP 4% is 1, 4-benzenediol. The drug is freely soluble in water and in alcohol. Chemically, hydroquinone is designated as p-dihydroxybenzene; the empirical formula is C6H6O2; molecular weight is 110.11 g/mol. The chemical structure is in the diagram below.</Description>
</NDC>
<NDC>
<NDCCode>62032-907-07</NDCCode>
<PackageDescription>1 KIT in 1 BOX (62032-907-07) * 1 BOTTLE, DROPPER in 1 CARTON / 30 mL in 1 BOTTLE, DROPPER * 1 BOTTLE, PUMP in 1 CARTON / 30 mL in 1 BOTTLE, PUMP * 1 TUBE in 1 CARTON (62032-050-54) / 48 g in 1 TUBE * 59 mL in 1 BOTTLE, PLASTIC * 60 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>62032-0907-07</NDC11Code>
<ProductNDC>62032-907</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Obagi Skintrinsiq Antioxidant Protocol</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20210801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Obagi Cosmeceuticals LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62032-106-10</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62032-106-10) / 30 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62032-0106-10</NDC11Code>
<ProductNDC>62032-106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Obagi C Rx System C Clarifying Serum</ProprietaryName>
<NonProprietaryName>Hydroquinone</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Obagi Cosmeceuticals LLC</LabelerName>
<SubstanceName>HYDROQUINONE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Depigmenting Activity [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.</IndicationAndUsage>
<Description>Hydroquinone is 1,4-benzenediol. Hydroquinone occurs as fine, white needles. The drug is freely soluble in water and in alcohol. Chemically, hydroquinone is designated as p-dihydroxybenzene; the empirical formula is C6H6O2; molecular weight is 110.11 g per mol. The chemical structure is in the diagram.</Description>
</NDC>
<NDC>
<NDCCode>62032-536-57</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (62032-536-57) * 85 g in 1 TUBE (62032-142-11) * 177 mL in 1 BOTTLE, PLASTIC * 198 mL in 1 BOTTLE, PLASTIC * 57 g in 1 BOTTLE, PLASTIC * 1 BOTTLE, GLASS in 1 CARTON > 30 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62032-0536-57</NDC11Code>
<ProductNDC>62032-536</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Obagi-c Fx System Normal-oily</ProprietaryName>
<ProprietaryNameSuffix>Skin Brightening System With Arbutin</ProprietaryNameSuffix>
<NonProprietaryName>Homosalate, Octisalate, And Zinc Oxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20191202</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Obagi Cosmeceuticals LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62032-537-58</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (62032-537-58) * 57 g in 1 BOTTLE, PLASTIC * 85 g in 1 TUBE * 177 mL in 1 BOTTLE, PLASTIC * 1 BOTTLE, GLASS in 1 CARTON > 30 mL in 1 BOTTLE, GLASS * 57 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>62032-0537-58</NDC11Code>
<ProductNDC>62032-537</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Obagi-c Fx System Normal-dry</ProprietaryName>
<ProprietaryNameSuffix>Skin Brightening System With Arbutin</ProprietaryNameSuffix>
<NonProprietaryName>Homosalate, Octisalate, And Zinc Oxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20191202</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Obagi Cosmeceuticals LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0409-3383-02</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (0409-3383-02) / 10 mL in 1 VIAL, SINGLE-USE (0409-3383-11) </PackageDescription>
<NDC11Code>00409-3383-02</NDC11Code>
<ProductNDC>0409-3383</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Piperacillin And Tazobactam</ProprietaryName>
<NonProprietaryName>Piperacillin And Tazobactam</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; PARENTERAL</RouteName>
<StartMarketingDate>20101021</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065362</ApplicationNumber>
<LabelerName>Hospira, Inc</LabelerName>
<SubstanceName>PIPERACILLIN SODIUM; TAZOBACTAM SODIUM</SubstanceName>
<StrengthNumber>2; .25</StrengthNumber>
<StrengthUnit>g/10mL; g/10mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101021</StartMarketingDatePackage>
<EndMarketingDatePackage>20261231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Piperacillin and tazobactam for injection is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1), 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2), 3 Skin and skin structure infections in adults (1.3), 4 Female pelvic infections in adults (1.4), 5 Community-acquired pneumonia in adults (1.5).</IndicationAndUsage>
<Description>Piperacillin and tazobactam for injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine‑carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2‑carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1‑azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is. Piperacillin and tazobactam for injection, USP, is a white to yellowish sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. The product does not contain excipients or preservatives. Dilute solutions are colorless to yellowish. Each piperacillin and tazobactam for injection, USP 2.25 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains 4.69 mEq (108 mg) of sodium. Each piperacillin and tazobactam for injection, USP 3.375 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 7.04 mEq (162 mg) of sodium. Each piperacillin and tazobactam for injection, USP 4.5 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each vial contains 9.39 mEq (216 mg) of sodium. Piperacillin and tazobactam for injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Meets USP Organic Impurities Procedure 3.</Description>
</NDC>
<NDC>
<NDCCode>0409-3383-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (0409-3383-10) / 10 mL in 1 VIAL, SINGLE-USE (0409-3383-11) </PackageDescription>
<NDC11Code>00409-3383-10</NDC11Code>
<ProductNDC>0409-3383</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Piperacillin And Tazobactam</ProprietaryName>
<NonProprietaryName>Piperacillin And Tazobactam</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; PARENTERAL</RouteName>
<StartMarketingDate>20101021</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Hospira, Inc</LabelerName>
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<StrengthNumber>2; .25</StrengthNumber>
<StrengthUnit>g/10mL; g/10mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
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<LastUpdate>2026-07-24</LastUpdate>
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<IndicationAndUsage>Piperacillin and tazobactam for injection is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1), 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2), 3 Skin and skin structure infections in adults (1.3), 4 Female pelvic infections in adults (1.4), 5 Community-acquired pneumonia in adults (1.5).</IndicationAndUsage>
<Description>Piperacillin and tazobactam for injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine‑carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2‑carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1‑azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is. Piperacillin and tazobactam for injection, USP, is a white to yellowish sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. The product does not contain excipients or preservatives. Dilute solutions are colorless to yellowish. Each piperacillin and tazobactam for injection, USP 2.25 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains 4.69 mEq (108 mg) of sodium. Each piperacillin and tazobactam for injection, USP 3.375 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 7.04 mEq (162 mg) of sodium. Each piperacillin and tazobactam for injection, USP 4.5 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each vial contains 9.39 mEq (216 mg) of sodium. Piperacillin and tazobactam for injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Meets USP Organic Impurities Procedure 3.</Description>
</NDC>
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<IndicationAndUsage>Piperacillin and tazobactam for injection is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1), 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2), 3 Skin and skin structure infections in adults (1.3), 4 Female pelvic infections in adults (1.4), 5 Community-acquired pneumonia in adults (1.5).</IndicationAndUsage>
<Description>Piperacillin and tazobactam for injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine‑carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2‑carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1‑azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is. Piperacillin and tazobactam for injection, USP, is a white to yellowish sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. The product does not contain excipients or preservatives. Dilute solutions are colorless to yellowish. Each piperacillin and tazobactam for injection, USP 2.25 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains 4.69 mEq (108 mg) of sodium. Each piperacillin and tazobactam for injection, USP 3.375 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 7.04 mEq (162 mg) of sodium. Each piperacillin and tazobactam for injection, USP 4.5 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each vial contains 9.39 mEq (216 mg) of sodium. Piperacillin and tazobactam for injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Meets USP Organic Impurities Procedure 3.</Description>
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<IndicationAndUsage>Piperacillin and tazobactam for injection is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1), 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2), 3 Skin and skin structure infections in adults (1.3), 4 Female pelvic infections in adults (1.4), 5 Community-acquired pneumonia in adults (1.5).</IndicationAndUsage>
<Description>Piperacillin and tazobactam for injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine‑carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2‑carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1‑azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is. Piperacillin and tazobactam for injection, USP, is a white to yellowish sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. The product does not contain excipients or preservatives. Dilute solutions are colorless to yellowish. Each piperacillin and tazobactam for injection, USP 2.25 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains 4.69 mEq (108 mg) of sodium. Each piperacillin and tazobactam for injection, USP 3.375 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 7.04 mEq (162 mg) of sodium. Each piperacillin and tazobactam for injection, USP 4.5 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each vial contains 9.39 mEq (216 mg) of sodium. Piperacillin and tazobactam for injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Meets USP Organic Impurities Procedure 3.</Description>
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<SubstanceName>PIPERACILLIN SODIUM; TAZOBACTAM SODIUM</SubstanceName>
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<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
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<IndicationAndUsage>Piperacillin and tazobactam for injection is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1), 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2), 3 Skin and skin structure infections in adults (1.3), 4 Female pelvic infections in adults (1.4), 5 Community-acquired pneumonia in adults (1.5).</IndicationAndUsage>
<Description>Piperacillin and tazobactam for injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine‑carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2‑carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1‑azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is. Piperacillin and tazobactam for injection, USP, is a white to yellowish sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. The product does not contain excipients or preservatives. Dilute solutions are colorless to yellowish. Each piperacillin and tazobactam for injection, USP 2.25 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains 4.69 mEq (108 mg) of sodium. Each piperacillin and tazobactam for injection, USP 3.375 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 7.04 mEq (162 mg) of sodium. Each piperacillin and tazobactam for injection, USP 4.5 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each vial contains 9.39 mEq (216 mg) of sodium. Piperacillin and tazobactam for injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Meets USP Organic Impurities Procedure 3.</Description>
</NDC>
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<SubstanceName>PIPERACILLIN SODIUM; TAZOBACTAM SODIUM</SubstanceName>
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<StrengthUnit>g/15mL; g/15mL</StrengthUnit>
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<IndicationAndUsage>Piperacillin and tazobactam for injection is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1), 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2), 3 Skin and skin structure infections in adults (1.3), 4 Female pelvic infections in adults (1.4), 5 Community-acquired pneumonia in adults (1.5).</IndicationAndUsage>
<Description>Piperacillin and tazobactam for injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine‑carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2‑carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1‑azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is. Piperacillin and tazobactam for injection, USP, is a white to yellowish sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. The product does not contain excipients or preservatives. Dilute solutions are colorless to yellowish. Each piperacillin and tazobactam for injection, USP 2.25 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains 4.69 mEq (108 mg) of sodium. Each piperacillin and tazobactam for injection, USP 3.375 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 7.04 mEq (162 mg) of sodium. Each piperacillin and tazobactam for injection, USP 4.5 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each vial contains 9.39 mEq (216 mg) of sodium. Piperacillin and tazobactam for injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Meets USP Organic Impurities Procedure 3.</Description>
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<IndicationAndUsage>Piperacillin and tazobactam for injection is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1), 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2), 3 Skin and skin structure infections in adults (1.3), 4 Female pelvic infections in adults (1.4), 5 Community-acquired pneumonia in adults (1.5).</IndicationAndUsage>
<Description>Piperacillin and tazobactam for injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine‑carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2‑carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1‑azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is. Piperacillin and tazobactam for injection, USP, is a white to yellowish sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. The product does not contain excipients or preservatives. Dilute solutions are colorless to yellowish. Each piperacillin and tazobactam for injection, USP 2.25 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains 4.69 mEq (108 mg) of sodium. Each piperacillin and tazobactam for injection, USP 3.375 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 7.04 mEq (162 mg) of sodium. Each piperacillin and tazobactam for injection, USP 4.5 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each vial contains 9.39 mEq (216 mg) of sodium. Piperacillin and tazobactam for injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Meets USP Organic Impurities Procedure 3.</Description>
</NDC>
<NDC>
<NDCCode>13668-539-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (13668-539-05) </PackageDescription>
<NDC11Code>13668-0539-05</NDC11Code>
<ProductNDC>13668-539</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eslicarbazepine Acetate</ProprietaryName>
<NonProprietaryName>Eslicarbazepine Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250506</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211227</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>ESLICARBAZEPINE ACETATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.</IndicationAndUsage>
<Description>The chemical name of eslicarbazepine acetate, USP is (S)-10-Acetoxy-10,11-dihydro-5H dibenz[b,f]azepine-5-carboxamide. Eslicarbazepine acetate, USP is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C 17H 16N 2O 3and its molecular weight is 296.32. The chemical structure is:. Eslicarbazepine acetate, USP is a white to almost white crystalline Powder. It is Freely soluble in Dimethylsulphoxide and Dichloromethane. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate, USP and the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and povidone (K-30).</Description>
</NDC>
<NDC>
<NDCCode>13668-539-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (13668-539-30) </PackageDescription>
<NDC11Code>13668-0539-30</NDC11Code>
<ProductNDC>13668-539</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eslicarbazepine Acetate</ProprietaryName>
<NonProprietaryName>Eslicarbazepine Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250506</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211227</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>ESLICARBAZEPINE ACETATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.</IndicationAndUsage>
<Description>The chemical name of eslicarbazepine acetate, USP is (S)-10-Acetoxy-10,11-dihydro-5H dibenz[b,f]azepine-5-carboxamide. Eslicarbazepine acetate, USP is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C 17H 16N 2O 3and its molecular weight is 296.32. The chemical structure is:. Eslicarbazepine acetate, USP is a white to almost white crystalline Powder. It is Freely soluble in Dimethylsulphoxide and Dichloromethane. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate, USP and the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and povidone (K-30).</Description>
</NDC>
<NDC>
<NDCCode>13668-539-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (13668-539-60) </PackageDescription>
<NDC11Code>13668-0539-60</NDC11Code>
<ProductNDC>13668-539</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eslicarbazepine Acetate</ProprietaryName>
<NonProprietaryName>Eslicarbazepine Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250506</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211227</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>ESLICARBAZEPINE ACETATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.</IndicationAndUsage>
<Description>The chemical name of eslicarbazepine acetate, USP is (S)-10-Acetoxy-10,11-dihydro-5H dibenz[b,f]azepine-5-carboxamide. Eslicarbazepine acetate, USP is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C 17H 16N 2O 3and its molecular weight is 296.32. The chemical structure is:. Eslicarbazepine acetate, USP is a white to almost white crystalline Powder. It is Freely soluble in Dimethylsulphoxide and Dichloromethane. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate, USP and the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and povidone (K-30).</Description>
</NDC>
<NDC>
<NDCCode>16590-030-25</NDCCode>
<PackageDescription>180 SPRAY, SUSPENSION in 1 BOTTLE, PUMP (16590-030-25)</PackageDescription>
<NDC11Code>16590-0030-25</NDC11Code>
<ProductNDC>16590-030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Beconase</ProprietaryName>
<ProprietaryNameSuffix>Aq</ProprietaryNameSuffix>
<NonProprietaryName>Beclomethasone Dipropionate Monohydrate</NonProprietaryName>
<DosageFormName>SPRAY, SUSPENSION</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>19891001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019389</ApplicationNumber>
<LabelerName>Stat Rx USA LLC</LabelerName>
<SubstanceName>BECLOMETHASONE DIPROPIONATE MONOHYDRATE</SubstanceName>
<StrengthNumber>42</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>BECONASE AQ Nasal Spray is indicated for the relief of the symptoms of seasonal or perennial allergic and nonallergic (vasomotor) rhinitis. Results from 2 clinical trials have shown that significant symptomatic relief was obtained within 3 days. However, symptomatic relief may not occur in some patients for as long as 2 weeks. BECONASE AQ Nasal Spray should not be continued beyond 3 weeks in the absence of significant symptomatic improvement. BECONASE AQ Nasal Spray should not be used in the presence of untreated localized infection involving the nasal mucosa. BECONASE AQ Nasal Spray is also indicated for the prevention of recurrence of nasal polyps following surgical removal. Clinical studies have shown that treatment of the symptoms associated with nasal polyps may have to be continued for several weeks or more before a therapeutic result can be fully assessed. Recurrence of symptoms due to polyps can occur after stopping treatment, depending on the severity of the disease.</IndicationAndUsage>
<Description>Beclomethasone dipropionate, monohydrate, the active component of BECONASE AQ Nasal Spray, is an anti-inflammatory steroid having the chemical name 9-chloro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, monohydrate and the following chemical structure. Beclomethasone 17,21-dipropionate is a diester of beclomethasone, a synthetic halogenated corticosteroid. Beclomethasone dipropionate, monohydrate is a white to creamy-white, odorless powder with a molecular weight of 539.06. It is very slightly soluble in water, very soluble in chloroform, and freely soluble in acetone and in ethanol. BECONASE AQ Nasal Spray is a metered-dose, manual pump spray unit containing a microcrystalline suspension of beclomethasone dipropionate, monohydrate equivalent to 42 mcg of beclomethasone dipropionate, calculated on the dried basis, in an aqueous medium containing microcrystalline cellulose, carboxymethylcellulose sodium, dextrose, benzalkonium chloride, polysorbate 80, and 0.25% v/w phenylethyl alcohol. The pH through expiry is 5.0 to 6.8. After initial priming (6 actuations), each actuation of the pump delivers from the nasal adapter 100 mg of suspension containing beclomethasone dipropionate, monohydrate equivalent to 42 mcg of beclomethasone dipropionate. If the pump is not used for 7 days, it should be primed until a fine spray appears. Each 25-g bottle of BECONASE AQ Nasal Spray provides 180 metered sprays.</Description>
</NDC>
<NDC>
<NDCCode>16590-539-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (16590-539-30)</PackageDescription>
<NDC11Code>16590-0539-30</NDC11Code>
<ProductNDC>16590-539</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zonisamide</ProprietaryName>
<NonProprietaryName>Zonisamide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060317</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077634</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>ZONISAMIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.</IndicationAndUsage>
<Description>Zonisamide is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The molecular formula is C8H8N2O3S with a molecular weight of 212.23. Zonisamide is a white powder, pKa = 10.2, and is moderately soluble in water (0.8 mg/mL) and 0.1 N HCl (0.5 mg/mL). The chemical structure is. Zonisamide is supplied for oral administration as capsules containing 25 mg, 50 mg or 100 mg zonisamide. Each capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, gelatin, and titanium dioxide. In addition, individual empty hard gelatin capsule shell contains:50 mg: Black iron oxide.100 mg: FD and C Blue #1 and FD and C Red #40. The imprinting ink contains black iron oxide, shellac glaze, propylene glycol and also contains either FD and C Blue No. 2, FD and C Red No. 40, FD and C Blue No. 1 and D and C Yellow No.10 or strong ammonia solution and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>16590-539-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (16590-539-60)</PackageDescription>
<NDC11Code>16590-0539-60</NDC11Code>
<ProductNDC>16590-539</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zonisamide</ProprietaryName>
<NonProprietaryName>Zonisamide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060317</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077634</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>ZONISAMIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.</IndicationAndUsage>
<Description>Zonisamide is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The molecular formula is C8H8N2O3S with a molecular weight of 212.23. Zonisamide is a white powder, pKa = 10.2, and is moderately soluble in water (0.8 mg/mL) and 0.1 N HCl (0.5 mg/mL). The chemical structure is. Zonisamide is supplied for oral administration as capsules containing 25 mg, 50 mg or 100 mg zonisamide. Each capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, gelatin, and titanium dioxide. In addition, individual empty hard gelatin capsule shell contains:50 mg: Black iron oxide.100 mg: FD and C Blue #1 and FD and C Red #40. The imprinting ink contains black iron oxide, shellac glaze, propylene glycol and also contains either FD and C Blue No. 2, FD and C Red No. 40, FD and C Blue No. 1 and D and C Yellow No.10 or strong ammonia solution and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>16590-539-82</NDCCode>
<PackageDescription>180 CAPSULE in 1 BOTTLE (16590-539-82)</PackageDescription>
<NDC11Code>16590-0539-82</NDC11Code>
<ProductNDC>16590-539</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zonisamide</ProprietaryName>
<NonProprietaryName>Zonisamide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060317</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077634</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>ZONISAMIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.</IndicationAndUsage>
<Description>Zonisamide is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The molecular formula is C8H8N2O3S with a molecular weight of 212.23. Zonisamide is a white powder, pKa = 10.2, and is moderately soluble in water (0.8 mg/mL) and 0.1 N HCl (0.5 mg/mL). The chemical structure is. Zonisamide is supplied for oral administration as capsules containing 25 mg, 50 mg or 100 mg zonisamide. Each capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, gelatin, and titanium dioxide. In addition, individual empty hard gelatin capsule shell contains:50 mg: Black iron oxide.100 mg: FD and C Blue #1 and FD and C Red #40. The imprinting ink contains black iron oxide, shellac glaze, propylene glycol and also contains either FD and C Blue No. 2, FD and C Red No. 40, FD and C Blue No. 1 and D and C Yellow No.10 or strong ammonia solution and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>16590-539-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (16590-539-90)</PackageDescription>
<NDC11Code>16590-0539-90</NDC11Code>
<ProductNDC>16590-539</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zonisamide</ProprietaryName>
<NonProprietaryName>Zonisamide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060317</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077634</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>ZONISAMIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.</IndicationAndUsage>
<Description>Zonisamide is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The molecular formula is C8H8N2O3S with a molecular weight of 212.23. Zonisamide is a white powder, pKa = 10.2, and is moderately soluble in water (0.8 mg/mL) and 0.1 N HCl (0.5 mg/mL). The chemical structure is. Zonisamide is supplied for oral administration as capsules containing 25 mg, 50 mg or 100 mg zonisamide. Each capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, gelatin, and titanium dioxide. In addition, individual empty hard gelatin capsule shell contains:50 mg: Black iron oxide.100 mg: FD and C Blue #1 and FD and C Red #40. The imprinting ink contains black iron oxide, shellac glaze, propylene glycol and also contains either FD and C Blue No. 2, FD and C Red No. 40, FD and C Blue No. 1 and D and C Yellow No.10 or strong ammonia solution and potassium hydroxide.</Description>
</NDC>
</NDCList>