{
"NDC": [
{
"NDCCode": "42926-165-15",
"PackageDescription": "1 BOTTLE, SPRAY in 1 PACKAGE (42926-165-15) > 15 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "42926-0165-15",
"ProductNDC": "42926-165",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lemon Verbena Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140508",
"EndMarketingDate": "20240831",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Mangiacotti, Inc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140508",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "For hand sanitizing to decrease bacteria on the skin ∙Recommended for repeated use."
},
{
"NDCCode": "42926-160-15",
"PackageDescription": "1 BOTTLE, SPRAY in 1 PACKAGE (42926-160-15) > 15 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "42926-0160-15",
"ProductNDC": "42926-160",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pomegranate Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140514",
"EndMarketingDate": "20240831",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Mangiacotti, Inc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140514",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "For hand sanitizing to decrease bacteria on the skin ∙Recommended for repeated use."
},
{
"NDCCode": "42926-161-15",
"PackageDescription": "1 BOTTLE, SPRAY in 1 PACKAGE (42926-161-15) > 15 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "42926-0161-15",
"ProductNDC": "42926-161",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ginger Lime Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140514",
"EndMarketingDate": "20171231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Mangiacotti, Inc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2018-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231",
"StartMarketingDatePackage": "20140514",
"EndMarketingDatePackage": "20171231",
"SamplePackage": "N"
},
{
"NDCCode": "42926-162-15",
"PackageDescription": "1 BOTTLE, SPRAY in 1 PACKAGE (42926-162-15) > 15 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "42926-0162-15",
"ProductNDC": "42926-162",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clementine Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140514",
"EndMarketingDate": "20240831",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Mangiacotti, Inc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140514",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "For hand sanitizing to decrease bacteria on the skin ∙Recommended for repeated use."
},
{
"NDCCode": "42926-163-15",
"PackageDescription": "1 BOTTLE, SPRAY in 1 PACKAGE (42926-163-15) > 15 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "42926-0163-15",
"ProductNDC": "42926-163",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ocean Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140514",
"EndMarketingDate": "20240831",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Mangiacotti, Inc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140514",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "For hand sanitizing to decrease bacteria on the skin ∙Recommended for repeated use."
},
{
"NDCCode": "42926-164-15",
"PackageDescription": "1 BOTTLE, SPRAY in 1 PACKAGE (42926-164-15) > 15 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "42926-0164-15",
"ProductNDC": "42926-164",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lavender Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140514",
"EndMarketingDate": "20240831",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Mangiacotti, Inc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140514",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "For hand sanitizing to decrease bacteria on the skin ∙Recommended for repeated use."
},
{
"NDCCode": "42926-166-15",
"PackageDescription": "1 BOTTLE, SPRAY in 1 PACKAGE (42926-166-15) > 15 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "42926-0166-15",
"ProductNDC": "42926-166",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Jasmine Plum Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180101",
"EndMarketingDate": "20240831",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Mangiacotti, Inc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180101",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "For hand sanitizing to decrease bacteria on the skin ∙Recommended for repeated use."
},
{
"NDCCode": "11673-165-22",
"PackageDescription": "15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (11673-165-22)",
"NDC11Code": "11673-0165-22",
"ProductNDC": "11673-165",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine And Pseudoephedrine Sulfate",
"NonProprietaryName": "Loratadine And Pseudoephedrine Sulfate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20041117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076557",
"LabelerName": "Target Corporation",
"SubstanceName": "LORATADINE; PSEUDOEPHEDRINE SULFATE",
"StrengthNumber": "10; 240",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:sneezingitchy, watery eyesrunny noseitching of the nose or throat."
},
{
"NDCCode": "20276-165-15",
"PackageDescription": "444 mL in 1 BOTTLE, PLASTIC (20276-165-15)",
"NDC11Code": "20276-0165-15",
"ProductNDC": "20276-165",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Hand Soap",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110930",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Delta Brands Inc",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".1",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "24208-399-15",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (24208-399-15) / 165 SPRAY, METERED in 1 BOTTLE, SPRAY",
"NDC11Code": "24208-0399-15",
"ProductNDC": "24208-399",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ipratropium Bromide",
"NonProprietaryName": "Ipratropium Bromide",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20030331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076103",
"LabelerName": "Bausch & Lomb Incorporated",
"SubstanceName": "IPRATROPIUM BROMIDE",
"StrengthNumber": "42",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20030331",
"SamplePackage": "N",
"IndicationAndUsage": "Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis. The safety and effectiveness of the use of Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) beyond four days in patients with the common cold or beyond three weeks in patients with seasonal allergic rhinitis has not been established.",
"Description": "The active ingredient in Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) is ipratropium bromide monohydrate. It is an anticholinergic agent chemically described as 8-azoniabicyclo [3.2.1] octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide monohydrate, (3-endo,8-syn)-: a synthetic quaternary ammonium compound, chemically related to atropine. Its structural formula is: ipratropium bromide monohydrate. Ipratropium bromide is a white to off-white crystalline substance, freely soluble in water and methanol, sparingly soluble in ethanol, and insoluble in non-polar media. In aqueous solution, it exists in an ionized state as a quaternary ammonium compound. Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) is a metered-dose, manual pump spray unit which delivers 42 mcg ipratropium bromide (on an anhydrous basis) per spray (70 microliters) in an isotonic, aqueous solution, pH-adjusted to 4.7 with hydrochloric acid and/or sodium hydroxide (if needed). It also contains benzalkonium chloride, edetate disodium, sodium chloride, and purified water. Each bottle contains 165 sprays."
},
{
"NDCCode": "25021-165-30",
"PackageDescription": "10 VIAL in 1 CARTON (25021-165-30) > 15 mL in 1 VIAL",
"NDC11Code": "25021-0165-30",
"ProductNDC": "25021-165",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Piperacillin, Tazobactam",
"NonProprietaryName": "Piperacillin Sodium, Tazobactam Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110616",
"EndMarketingDate": "20230731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065498",
"LabelerName": "Sagent Pharmaceuticals",
"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": "Deprecated",
"LastUpdate": "2023-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110616",
"EndMarketingDatePackage": "20230731",
"SamplePackage": "N"
},
{
"NDCCode": "41250-165-22",
"PackageDescription": "15 BLISTER PACK in 1 CARTON (41250-165-22) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "41250-0165-22",
"ProductNDC": "41250-165",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief D",
"NonProprietaryName": "Loratadine, Pseudoephedrine Sulfate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20030605",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075706",
"LabelerName": "Meijer Distribution Inc",
"SubstanceName": "PSEUDOEPHEDRINE SULFATE; LORATADINE",
"StrengthNumber": "240; 10",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-04-05",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "42254-355-15",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (42254-355-15) > 165 SPRAY, METERED in 1 BOTTLE, SPRAY",
"NDC11Code": "42254-0355-15",
"ProductNDC": "42254-355",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ipratropium Bromide",
"NonProprietaryName": "Ipratropium Bromide",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20030331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076103",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "IPRATROPIUM BROMIDE",
"StrengthNumber": "42",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ipratropium bromide nasal solution 0.06% (Nasal Spray) is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. Ipratropium bromide nasal solution 0.06% (Nasal Spray) does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis. The safety and effectiveness of the use of ipratropium bromide nasal solution 0.06% (Nasal Spray) beyond four days in patients with the common cold or beyond three weeks in patients with seasonal allergic rhinitis has not been established.",
"Description": "The active ingredient in Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) is ipratropium bromide monohydrate. It is an anticholinergic agent chemically described as 8-azoniabicyclo [3.2.1]octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide monohydrate, (3-endo,8-syn)-: a synthetic quaternary ammonium compound, chemically related to atropine. Its structural formula is. ipratropium bromide monohydrate. C20H30BrNO3 H2OMol. Wt. 430.4. Ipratropium bromide is a white to off-white crystalline substance, freely soluble in water and methanol, sparingly soluble in ethanol, and insoluble in non-polar media. In aqueous solution, it exists in an ionized state as a quaternary ammonium compound. Ipratropium bromide nasal solution 0.06% (Nasal Spray) is a metered-dose, manual pump spray unit which delivers 42 mcg ipratropium bromide (on an anhydrous basis) per spray (70 μL) in an isotonic aqueous solution, pH-adjusted to 4.7 with hydrochloric acid and/or sodium hydroxide (if needed). It also contains benzalkonium chloride, edetate disodium, sodium chloride, and purified water. Each bottle contains 165 sprays."
},
{
"NDCCode": "50268-165-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX (50268-165-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-165-11) ",
"NDC11Code": "50268-0165-15",
"ProductNDC": "50268-165",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorpromazine Hydrochloride",
"NonProprietaryName": "Chlorpromazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209755",
"LabelerName": "AvPAK",
"SubstanceName": "CHLORPROMAZINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200214",
"SamplePackage": "N",
"IndicationAndUsage": "For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.",
"Description": "Chlorpromazine hydrochloride, a dimethylamine derivative of phenothiazine, has a chemical formula of 2-chloro-10-[3-(dimethylamino) propyl] phenothiazine monohydrochloride. It is available in tablets for oral administration. It has the following structural formula. Chlorpromazine hydrochloride, USP is a white to almost white crystalline powder. It is very soluble in water, freely soluble in ethanol (96%). Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, 100 mg, or 200 mg of chlorpromazine hydrochloride, USP. Inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, sodium lauryl sulfate and titanium dioxide. Each tablet is imprinted with black pharmaceutical ink which contains: ammonium hydroxide, ferrosoferric oxide, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac."
},
{
"NDCCode": "52125-672-15",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (52125-672-15) > 165 SPRAY in 1 BOTTLE, SPRAY",
"NDC11Code": "52125-0672-15",
"ProductNDC": "52125-672",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ipratropium Bromide",
"NonProprietaryName": "Ipratropium Bromide",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20140109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076598",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "IPRATROPIUM BROMIDE ANHYDROUS",
"StrengthNumber": "42",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-02-13"
},
{
"NDCCode": "54288-165-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (54288-165-01) / 15 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "54288-0165-01",
"ProductNDC": "54288-165",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carboplatin",
"NonProprietaryName": "Carboplatin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207324",
"LabelerName": "BPI Labs LLC",
"SubstanceName": "CARBOPLATIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]",
"Status": "Active",
"LastUpdate": "2025-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230731",
"SamplePackage": "N",
"IndicationAndUsage": "Initial Treatment of Advanced Ovarian Carcinoma Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see CLINICAL STUDIES). There is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival (≥ 3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup. Secondary Treatment of Advanced Ovarian Carcinoma Carboplatin injection is indicated for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with cisplatin. Within the group of patients previously treated with cisplatin, those who have developed progressive disease while receiving cisplatin therapy may have a decreased response rate.",
"Description": "Carboplatin injection,USP is supplied as a sterile, pyrogen-free, 10 mg/mL aqueous solution of carboplatin, USP. Carboplatin, USP is a platinum coordination compound. The chemical name for carboplatin, USP is platinum, diammine [1,1-cyclobutane dicarboxylato(2-)-0,0’]-,(SP-4-2), and carboplatin, USP has the following structural formula. C6H12N2O4Pt M.W. 371.25Carboplatin, USP is a crystalline powder. It is soluble in water at a rate of approximately 14 mg/mL, and the pH of a 1% solution is 5 to 7. It is virtually insoluble in ethanol, acetone, and dimethylacetamide."
},
{
"NDCCode": "61649-165-15",
"PackageDescription": "150 g in 1 TUBE (61649-165-15) ",
"NDC11Code": "61649-0165-15",
"ProductNDC": "61649-165",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Attitude Oatmeal Sensitive Mineral Sunscreen Unscented Spf 30",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20231127",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "9055-7588 Quebec Inc. DBA Attitude",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "20",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2024-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231127",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "63776-165-15",
"PackageDescription": "50 mL in 1 BOTTLE (63776-165-15) ",
"NDC11Code": "63776-0165-15",
"ProductNDC": "63776-165",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Foods",
"NonProprietaryName": "Activated Charcoal, Ageratina Aromatica Root, Ferrous Iodide, Gelsemium Sempervirens Root, Calcium Sulfide, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Iodine, Potassium Gluconate, Lycopodium Clavatum Spore, Cajuput Oil, Black Currant, Rosa Canina Fruit, Serotonin, Xanthine, Almond, Apple, Banana, Barley, Bean, Beef, Cashew, Casein, Emmental Cultured, Casein, Lactococcus Lactis Cultured, Casein, Lactococcus Lactis Cultured Aged, Casein, Lactococcus Lactis Cultured",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
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"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 1; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 1; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
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"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20171002",
"SamplePackage": "N"
},
{
"NDCCode": "63981-165-22",
"PackageDescription": "15 BLISTER PACK in 1 CARTON (63981-165-22) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "63981-0165-22",
"ProductNDC": "63981-165",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kirkland Signature Allerclear D 24hr",
"NonProprietaryName": "Loratadine, Pseudoephedrine Sulfate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20070521",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075706",
"LabelerName": "Costco Wholesale Company",
"SubstanceName": "PSEUDOEPHEDRINE SULFATE; LORATADINE",
"StrengthNumber": "240; 10",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-11-08"
},
{
"NDCCode": "64220-165-03",
"PackageDescription": "15 kg in 1 CANISTER (64220-165-03) ",
"NDC11Code": "64220-0165-03",
"ProductNDC": "64220-165",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20240804",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Zhejiang Huahai Pharmaceutical Co., Ltd.",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-08-07",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "04-AUG-24"
},
{
"NDCCode": "64220-165-06",
"PackageDescription": "15 kg in 1 DRUM (64220-165-06) ",
"NDC11Code": "64220-0165-06",
"ProductNDC": "64220-165",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20240804",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Zhejiang Huahai Pharmaceutical Co., Ltd.",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-08-07",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "04-AUG-24"
},
{
"NDCCode": "68546-490-42",
"PackageDescription": "2 KIT in 1 BLISTER PACK (68546-490-42) / 1 KIT in 1 KIT * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-163-15) * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-165-15) * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-161-15) ",
"NDC11Code": "68546-0490-42",
"ProductNDC": "68546-490",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Austedo Xr",
"NonProprietaryName": "Deutetrabenazine",
"DosageFormName": "KIT",
"StartMarketingDate": "20230221",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216354",
"LabelerName": "Teva Neuroscience, Inc.",
"Status": "Deprecated",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230221",
"EndMarketingDatePackage": "20250630",
"SamplePackage": "Y",
"IndicationAndUsage": "AUSTEDO XR® and AUSTEDO® are indicated in adults for the treatment of: 1 chorea associated with Huntington’s disease [see Clinical Studies (14.1)], 2 tardive dyskinesia [see Clinical Studies (14.2)].",
"Description": "AUSTEDO XR extended-release tablets and AUSTEDO tablets are formulated with deutetrabenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor for oral administration. The molecular weight of deutetrabenazine is 323.46; the pKa is 6.31. Deutetrabenazine is a hexahydro-dimethoxybenzoquinolizine derivative and has the following chemical name: (RR, SS)-1, 3, 4, 6, 7, 11b-hexahydro-9, 10-di(methoxy-d3)-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one. The molecular formula for deutetrabenazine is C19H21D6NO3. Deutetrabenazine is a racemic mixture containing the following structures. Deutetrabenazine is a white to slightly yellow crystalline powder that is sparingly soluble in water and soluble in ethanol.AUSTEDO XR. AUSTEDO XR extended-release tablets contain 6 mg, 12 mg, 18 mg, 24 mg, 30 mg, 36 mg, 42 mg, or 48 mg deutetrabenazine, and the following inactive ingredients: ammonium hydroxide, black iron oxide, butyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, cellulose acetate, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, magnesium stearate, polyethylene glycol, polyethylene glycol 3350, polyethylene oxide, polyvinyl alcohol, propylene glycol, shellac, sodium chloride, talc, titanium dioxide, and FD&C red #40 lake. The 6 mg, 12 mg, 18 mg, 30 mg, 36 mg, and 42 mg extended-release tablets also contain FD&C yellow #6 lake. The 6 mg, 12 mg, 24 mg, and 36 mg extended-release tablets also contain FD&C blue #2 lake. The 18 mg extended-release tablets also contain carmine.AUSTEDO XR Delivery System Components and Performance AUSTEDO XR uses osmotic pressure to deliver deutetrabenazine at a controlled rate. The delivery system, which resembles a round tablet in appearance, consists of a bilayer core tablet that contains deutetrabenazine along with other excipients. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool. AUSTEDO. AUSTEDO tablets contain 6 mg, 9 mg, or 12 mg deutetrabenazine, and the following inactive ingredients: ammonium hydroxide, black iron oxide, butyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, polysorbate 80, polyvinyl alcohol, povidone, propylene glycol, shellac, talc, titanium dioxide, and FD&C blue #2 lake. The 6 mg tablets also contain FD&C red #40 lake. The 12 mg tablets also contain FD&C yellow #6 lake."
},
{
"NDCCode": "68546-490-52",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (68546-490-52) / 1 KIT in 1 BLISTER PACK * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-163-15) * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-165-15) * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-161-15) ",
"NDC11Code": "68546-0490-52",
"ProductNDC": "68546-490",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Austedo Xr",
"NonProprietaryName": "Deutetrabenazine",
"DosageFormName": "KIT",
"StartMarketingDate": "20230221",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216354",
"LabelerName": "Teva Neuroscience, Inc.",
"Status": "Deprecated",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230221",
"EndMarketingDatePackage": "20250630",
"SamplePackage": "N",
"IndicationAndUsage": "AUSTEDO XR® and AUSTEDO® are indicated in adults for the treatment of: 1 chorea associated with Huntington’s disease [see Clinical Studies (14.1)], 2 tardive dyskinesia [see Clinical Studies (14.2)].",
"Description": "AUSTEDO XR extended-release tablets and AUSTEDO tablets are formulated with deutetrabenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor for oral administration. The molecular weight of deutetrabenazine is 323.46; the pKa is 6.31. Deutetrabenazine is a hexahydro-dimethoxybenzoquinolizine derivative and has the following chemical name: (RR, SS)-1, 3, 4, 6, 7, 11b-hexahydro-9, 10-di(methoxy-d3)-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one. The molecular formula for deutetrabenazine is C19H21D6NO3. Deutetrabenazine is a racemic mixture containing the following structures. Deutetrabenazine is a white to slightly yellow crystalline powder that is sparingly soluble in water and soluble in ethanol.AUSTEDO XR. AUSTEDO XR extended-release tablets contain 6 mg, 12 mg, 18 mg, 24 mg, 30 mg, 36 mg, 42 mg, or 48 mg deutetrabenazine, and the following inactive ingredients: ammonium hydroxide, black iron oxide, butyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, cellulose acetate, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, magnesium stearate, polyethylene glycol, polyethylene glycol 3350, polyethylene oxide, polyvinyl alcohol, propylene glycol, shellac, sodium chloride, talc, titanium dioxide, and FD&C red #40 lake. The 6 mg, 12 mg, 18 mg, 30 mg, 36 mg, and 42 mg extended-release tablets also contain FD&C yellow #6 lake. The 6 mg, 12 mg, 24 mg, and 36 mg extended-release tablets also contain FD&C blue #2 lake. The 18 mg extended-release tablets also contain carmine.AUSTEDO XR Delivery System Components and Performance AUSTEDO XR uses osmotic pressure to deliver deutetrabenazine at a controlled rate. The delivery system, which resembles a round tablet in appearance, consists of a bilayer core tablet that contains deutetrabenazine along with other excipients. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool. AUSTEDO. AUSTEDO tablets contain 6 mg, 9 mg, or 12 mg deutetrabenazine, and the following inactive ingredients: ammonium hydroxide, black iron oxide, butyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, polysorbate 80, polyvinyl alcohol, povidone, propylene glycol, shellac, talc, titanium dioxide, and FD&C blue #2 lake. The 6 mg tablets also contain FD&C red #40 lake. The 12 mg tablets also contain FD&C yellow #6 lake."
},
{
"NDCCode": "68682-399-15",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (68682-399-15) / 165 SPRAY, METERED in 1 BOTTLE, SPRAY",
"NDC11Code": "68682-0399-15",
"ProductNDC": "68682-399",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ipratropium Bromide",
"NonProprietaryName": "Ipratropium Bromide",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20250601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076103",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "IPRATROPIUM BROMIDE",
"StrengthNumber": "42",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
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"IndicationAndUsage": "Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis. The safety and effectiveness of the use of Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) beyond four days in patients with the common cold or beyond three weeks in patients with seasonal allergic rhinitis has not been established.",
"Description": "The active ingredient in Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) is ipratropium bromide monohydrate. It is an anticholinergic agent chemically described as 8-azoniabicyclo [3.2.1] octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide monohydrate, (3-endo,8-syn)-: a synthetic quaternary ammonium compound, chemically related to atropine. Its structural formula is: ipratropium bromide monohydrate. Ipratropium bromide is a white to off-white crystalline substance, freely soluble in water and methanol, sparingly soluble in ethanol, and insoluble in non-polar media. In aqueous solution, it exists in an ionized state as a quaternary ammonium compound. Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) is a metered-dose, manual pump spray unit which delivers 42 mcg ipratropium bromide (on an anhydrous basis) per spray (70 microliters) in an isotonic, aqueous solution, pH-adjusted to 4.7 with hydrochloric acid and/or sodium hydroxide (if needed). It also contains benzalkonium chloride, edetate disodium dihydrate, sodium chloride, and purified water. Each bottle contains 165 sprays."
},
{
"NDCCode": "71919-165-07",
"PackageDescription": "15 mL in 1 VIAL, GLASS (71919-165-07) ",
"NDC11Code": "71919-0165-07",
"ProductNDC": "71919-165",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Carduus Benedictus",
"NonProprietaryName": "Centaurea Benedicta",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121121",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CENTAUREA BENEDICTA",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20121121",
"SamplePackage": "N"
},
{
"NDCCode": "85766-165-15",
"PackageDescription": "1 CARTON in 1 CARTON (85766-165-15) / 15 mL in 1 CARTON",
"NDC11Code": "85766-0165-15",
"ProductNDC": "85766-165",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Goodsense Eye Drops Advanced Relief Moisturizer",
"NonProprietaryName": "Dextran, Polyethylene Glycol 400, Povidone, Tetrahydrozoline Hcl",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20260207",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M018",
"LabelerName": "Sportpharm LLC",
"SubstanceName": "POLYETHYLENE GLYCOL 400; TETRAHYDROZOLINE HYDROCHLORIDE; POVIDONE; DEXTRAN 70",
"StrengthNumber": "1; .05; 1; .1",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Pharm_Classes": "Increased Intravascular Volume [PE], Osmotic Activity [MoA], Plasma Volume Expander [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260207",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 relieves redness of the eye due to minor eye irritations, 2 as a lubricant to prevent further irritation or to relieve dryness of the eye."
},
{
"NDCCode": "85766-242-15",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (85766-242-15) / 165 SPRAY, METERED in 1 BOTTLE, SPRAY",
"NDC11Code": "85766-0242-15",
"ProductNDC": "85766-242",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ipratropium Bromide",
"NonProprietaryName": "Ipratropium Bromide",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20250703",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217886",
"LabelerName": "Sportpharm LLC",
"SubstanceName": "IPRATROPIUM BROMIDE",
"StrengthNumber": "42",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260714",
"SamplePackage": "N",
"IndicationAndUsage": "Ipratropium bromide nasal solution, 0.06% is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. Ipratropium bromide 0.06% does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis. The safety and effectiveness of the use of ipratropium bromide 0.06% beyond four days in patients with the common cold or beyond three weeks in patients with seasonal allergic rhinitis has not been established.",
"Description": "The active ingredient in ipratropium bromide nasal solution is ipratropium bromide, USP (as the monohydrate). It is an anticholinergic agent chemically described as 8-azoniabicyclo (3.2.1) octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate ( endo,syn)-, (±)-: a synthetic quaternary ammonium compound, chemically related to atropine. Its structural formula is:. Ipratropium bromide, USP is a white to off-white, crystalline powder. It is soluble in water, freely soluble in methanol and slightly soluble in ethanol (96%). Ipratropium bromide nasal solution, 0.06% is a metered-dose, manual pump spray unit which delivers 42 mcg ipratropium bromide, USP (on an anhydrous basis) per spray (70 mcL) in an isotonic, aqueous solution with pH-adjusted to 4.7 with hydrochloric acid and sodium hydroxide (if needed). It also contains benzalkonium chloride, edetate disodium, purified water and sodium chloride. Each bottle contains 165 metered sprays."
},
{
"NDCCode": "0026-3950-50",
"PackageDescription": "1 KIT in 1 BOX (0026-3950-50) * 5 mL in 1 VIAL (0026-4950-99) * 5 mL in 1 SYRINGE (0026-0426-05) * 5 mL in 1 VIAL, SINGLE-USE (0026-4950-01) * 5 mL in 1 SYRINGE (0026-0426-15) ",
"NDC11Code": "00026-3950-50",
"ProductNDC": "0026-3950",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Jivi",
"NonProprietaryName": "Antihemophilic Factor (recombinant) Pegylated-aucl",
"DosageFormName": "KIT",
"StartMarketingDate": "20241202",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125661",
"LabelerName": "Bayer HealthCare LLC",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241202",
"SamplePackage": "N",
"IndicationAndUsage": "JIVI, is indicated for use in previously treated adults and pediatric patients 7 years of age and older with hemophilia A (congenital Factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes .",
"Description": "JIVI [antihemophilic factor (recombinant), PEGylated-aucl] is a sterile, nonpyrogenic, preservative-free, white to slightly yellow lyophilized powder for reconstitution with sterile Water for Injection (sWFI) as diluent for intravenous (IV) administration. The product is supplied in single-dose vials containing dosage strengths of 500, 1000, 2000 and 3000 IU in 2.5 mL fill size and 4000 IU in 5 mL fill size. For each dosage strength, the actual assayed potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sWFI, prefilled diluent syringe. The 500, 1000, 2000, and 3000 IU vials of JIVI are formulated with the following excipients: 59 mg glycine, 27 mg sucrose, 8.4 mg histidine, 4.7 mg sodium chloride, 0.7 mg calcium chloride, and 0.216 mg polysorbate 80. The 4000 IU vial of Jivi is formulated with the following quantities of these excipients: 114 mg glycine, 52 mg sucrose, 16.1 mg histidine, 9.1 mg sodium chloride, 1.9 mg calcium chloride, and 0.416 mg polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. The specific activity of JIVI is approximately 10,000 IU/mg protein. The active protein (or starting molecule), prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells. JIVI is produced by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was selected for conjugation to provide both a consistent coagulation activity and high PEGylation efficiency. The molecular weight of JIVI is approximately 234 kDa based on the calculated average molecular weight of the BDD-rFVIII variant of 165 kDa, plus glycosylation (~4 kDa), and the average molecular weight of the PEG-maleimide of approximately 60 kDa. Functional characterization of JIVI shows comparable mechanism of action to that of rFVIII product with an extended plasma half-life [see Clinical Pharmacology (12.1)]. The manufacturing process of JIVI involves propagation of the recombinant production cell line with the harvest isolation process consisting of continuous filtration of tissue culture fluid and anion exchange chromatography on a membrane adsorber capsule. The process intermediate is purified from process- and product-related impurities using a series of chromatography and filtration steps, including 20 nm viral filtration, prior to conjugation to the 60 kDa maleimide PEG moiety. The mono-PEGylated JIVI active molecule is separated from product-related species by chromatography and then formulated by ultrafiltration. The cell culture, PEGylation, purification process and formulation used in the manufacture of JIVI do not use any additives of human or animal origins."
},
{
"NDCCode": "0026-3950-99",
"PackageDescription": "1 KIT in 1 BOX (0026-3950-99) * 5 mL in 1 VIAL (0026-4950-99) * 5 mL in 1 SYRINGE (0026-0426-05) * 5 mL in 1 VIAL, SINGLE-USE (0026-4950-01) * 5 mL in 1 SYRINGE (0026-0426-15) ",
"NDC11Code": "00026-3950-99",
"ProductNDC": "0026-3950",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Jivi",
"NonProprietaryName": "Antihemophilic Factor (recombinant) Pegylated-aucl",
"DosageFormName": "KIT",
"StartMarketingDate": "20241202",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125661",
"LabelerName": "Bayer HealthCare LLC",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241202",
"SamplePackage": "N",
"IndicationAndUsage": "JIVI, is indicated for use in previously treated adults and pediatric patients 7 years of age and older with hemophilia A (congenital Factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes .",
"Description": "JIVI [antihemophilic factor (recombinant), PEGylated-aucl] is a sterile, nonpyrogenic, preservative-free, white to slightly yellow lyophilized powder for reconstitution with sterile Water for Injection (sWFI) as diluent for intravenous (IV) administration. The product is supplied in single-dose vials containing dosage strengths of 500, 1000, 2000 and 3000 IU in 2.5 mL fill size and 4000 IU in 5 mL fill size. For each dosage strength, the actual assayed potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sWFI, prefilled diluent syringe. The 500, 1000, 2000, and 3000 IU vials of JIVI are formulated with the following excipients: 59 mg glycine, 27 mg sucrose, 8.4 mg histidine, 4.7 mg sodium chloride, 0.7 mg calcium chloride, and 0.216 mg polysorbate 80. The 4000 IU vial of Jivi is formulated with the following quantities of these excipients: 114 mg glycine, 52 mg sucrose, 16.1 mg histidine, 9.1 mg sodium chloride, 1.9 mg calcium chloride, and 0.416 mg polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. The specific activity of JIVI is approximately 10,000 IU/mg protein. The active protein (or starting molecule), prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells. JIVI is produced by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was selected for conjugation to provide both a consistent coagulation activity and high PEGylation efficiency. The molecular weight of JIVI is approximately 234 kDa based on the calculated average molecular weight of the BDD-rFVIII variant of 165 kDa, plus glycosylation (~4 kDa), and the average molecular weight of the PEG-maleimide of approximately 60 kDa. Functional characterization of JIVI shows comparable mechanism of action to that of rFVIII product with an extended plasma half-life [see Clinical Pharmacology (12.1)]. The manufacturing process of JIVI involves propagation of the recombinant production cell line with the harvest isolation process consisting of continuous filtration of tissue culture fluid and anion exchange chromatography on a membrane adsorber capsule. The process intermediate is purified from process- and product-related impurities using a series of chromatography and filtration steps, including 20 nm viral filtration, prior to conjugation to the 60 kDa maleimide PEG moiety. The mono-PEGylated JIVI active molecule is separated from product-related species by chromatography and then formulated by ultrafiltration. The cell culture, PEGylation, purification process and formulation used in the manufacture of JIVI do not use any additives of human or animal origins."
},
{
"NDCCode": "0078-0569-12",
"PackageDescription": "15 BLISTER PACK in 1 CARTON (0078-0569-12) / 1 KIT in 1 BLISTER PACK (0078-0569-61) * 3 mL in 1 VIAL, SINGLE-USE * 1.2 mL in 1 SYRINGE",
"NDC11Code": "00078-0569-12",
"ProductNDC": "0078-0569",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Extavia",
"NonProprietaryName": "Interferon Beta-1b",
"DosageFormName": "KIT",
"StartMarketingDate": "20090814",
"EndMarketingDate": "20240531",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125290",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090814",
"EndMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "EXTAVIA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Interferon beta-1b is a purified, sterile, lyophilized protein product produced by recombinant DNA techniques. Interferon beta-1b is manufactured by bacterial fermentation of a strain of Escherichia coli that bears a genetically engineered plasmid containing the gene for human interferon betaser17. The native gene was obtained from human fibroblasts and altered in a way that substitutes serine for the cysteine residue found at position 17. Interferon beta-1b has 165 amino acids and an approximate molecular weight of 18,500 daltons. It does not include the carbohydrate side chains found in the natural material. The specific activity of EXTAVIA is approximately 32 million international units (IU)/mg interferon beta-1b. Each vial contains 0.3 mg of interferon beta-1b. The unit measurement is derived by comparing the antiviral activity of the product to the World Health Organization (WHO) reference standard of recombinant human interferon beta. Mannitol, USP and albumin (human), USP (15 mg each/vial) are added as stabilizers. EXTAVIA (interferon beta-1b) for injection is a sterile, preservative-free, white to off-white lyophilized powder, for subcutaneous injection after reconstitution with the diluent supplied (0.54% sodium chloride solution, USP). Each vial contains albumin (human), USP (15 mg), and mannitol, USP (15 mg)."
}
]
}
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<NonProprietaryName>Loratadine And Pseudoephedrine Sulfate</NonProprietaryName>
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<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
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<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:sneezingitchy, watery eyesrunny noseitching of the nose or throat.</IndicationAndUsage>
</NDC>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Hand Soap</ProprietaryName>
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<RouteName>TOPICAL</RouteName>
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<LabelerName>Delta Brands Inc</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
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<ProductNDC>24208-399</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ipratropium Bromide</ProprietaryName>
<NonProprietaryName>Ipratropium Bromide</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20030331</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076103</ApplicationNumber>
<LabelerName>Bausch & Lomb Incorporated</LabelerName>
<SubstanceName>IPRATROPIUM BROMIDE</SubstanceName>
<StrengthNumber>42</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<IndicationAndUsage>Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis. The safety and effectiveness of the use of Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) beyond four days in patients with the common cold or beyond three weeks in patients with seasonal allergic rhinitis has not been established.</IndicationAndUsage>
<Description>The active ingredient in Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) is ipratropium bromide monohydrate. It is an anticholinergic agent chemically described as 8-azoniabicyclo [3.2.1] octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide monohydrate, (3-endo,8-syn)-: a synthetic quaternary ammonium compound, chemically related to atropine. Its structural formula is: ipratropium bromide monohydrate. Ipratropium bromide is a white to off-white crystalline substance, freely soluble in water and methanol, sparingly soluble in ethanol, and insoluble in non-polar media. In aqueous solution, it exists in an ionized state as a quaternary ammonium compound. Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) is a metered-dose, manual pump spray unit which delivers 42 mcg ipratropium bromide (on an anhydrous basis) per spray (70 microliters) in an isotonic, aqueous solution, pH-adjusted to 4.7 with hydrochloric acid and/or sodium hydroxide (if needed). It also contains benzalkonium chloride, edetate disodium, sodium chloride, and purified water. Each bottle contains 165 sprays.</Description>
</NDC>
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<ProductNDC>25021-165</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Piperacillin, Tazobactam</ProprietaryName>
<NonProprietaryName>Piperacillin Sodium, Tazobactam Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20110616</StartMarketingDate>
<EndMarketingDate>20230731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065498</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>PIPERACILLIN SODIUM; TAZOBACTAM SODIUM</SubstanceName>
<StrengthNumber>3; .375</StrengthNumber>
<StrengthUnit>g/15mL; g/15mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110616</StartMarketingDatePackage>
<EndMarketingDatePackage>20230731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>41250-165-22</NDCCode>
<PackageDescription>15 BLISTER PACK in 1 CARTON (41250-165-22) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>41250-0165-22</NDC11Code>
<ProductNDC>41250-165</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Relief D</ProprietaryName>
<NonProprietaryName>Loratadine, Pseudoephedrine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030605</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075706</ApplicationNumber>
<LabelerName>Meijer Distribution Inc</LabelerName>
<SubstanceName>PSEUDOEPHEDRINE SULFATE; LORATADINE</SubstanceName>
<StrengthNumber>240; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-04-05</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>42254-355-15</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (42254-355-15) > 165 SPRAY, METERED in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>42254-0355-15</NDC11Code>
<ProductNDC>42254-355</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ipratropium Bromide</ProprietaryName>
<NonProprietaryName>Ipratropium Bromide</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20030331</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076103</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>IPRATROPIUM BROMIDE</SubstanceName>
<StrengthNumber>42</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ipratropium bromide nasal solution 0.06% (Nasal Spray) is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. Ipratropium bromide nasal solution 0.06% (Nasal Spray) does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis. The safety and effectiveness of the use of ipratropium bromide nasal solution 0.06% (Nasal Spray) beyond four days in patients with the common cold or beyond three weeks in patients with seasonal allergic rhinitis has not been established.</IndicationAndUsage>
<Description>The active ingredient in Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) is ipratropium bromide monohydrate. It is an anticholinergic agent chemically described as 8-azoniabicyclo [3.2.1]octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide monohydrate, (3-endo,8-syn)-: a synthetic quaternary ammonium compound, chemically related to atropine. Its structural formula is. ipratropium bromide monohydrate. C20H30BrNO3 H2OMol. Wt. 430.4. Ipratropium bromide is a white to off-white crystalline substance, freely soluble in water and methanol, sparingly soluble in ethanol, and insoluble in non-polar media. In aqueous solution, it exists in an ionized state as a quaternary ammonium compound. Ipratropium bromide nasal solution 0.06% (Nasal Spray) is a metered-dose, manual pump spray unit which delivers 42 mcg ipratropium bromide (on an anhydrous basis) per spray (70 μL) in an isotonic aqueous solution, pH-adjusted to 4.7 with hydrochloric acid and/or sodium hydroxide (if needed). It also contains benzalkonium chloride, edetate disodium, sodium chloride, and purified water. Each bottle contains 165 sprays.</Description>
</NDC>
<NDC>
<NDCCode>50268-165-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX (50268-165-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-165-11) </PackageDescription>
<NDC11Code>50268-0165-15</NDC11Code>
<ProductNDC>50268-165</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorpromazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Chlorpromazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209755</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>CHLORPROMAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.</IndicationAndUsage>
<Description>Chlorpromazine hydrochloride, a dimethylamine derivative of phenothiazine, has a chemical formula of 2-chloro-10-[3-(dimethylamino) propyl] phenothiazine monohydrochloride. It is available in tablets for oral administration. It has the following structural formula. Chlorpromazine hydrochloride, USP is a white to almost white crystalline powder. It is very soluble in water, freely soluble in ethanol (96%). Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, 100 mg, or 200 mg of chlorpromazine hydrochloride, USP. Inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, sodium lauryl sulfate and titanium dioxide. Each tablet is imprinted with black pharmaceutical ink which contains: ammonium hydroxide, ferrosoferric oxide, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>52125-672-15</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (52125-672-15) > 165 SPRAY in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>52125-0672-15</NDC11Code>
<ProductNDC>52125-672</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ipratropium Bromide</ProprietaryName>
<NonProprietaryName>Ipratropium Bromide</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20140109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076598</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>IPRATROPIUM BROMIDE ANHYDROUS</SubstanceName>
<StrengthNumber>42</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-02-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>54288-165-01</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (54288-165-01) / 15 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>54288-0165-01</NDC11Code>
<ProductNDC>54288-165</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carboplatin</ProprietaryName>
<NonProprietaryName>Carboplatin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207324</ApplicationNumber>
<LabelerName>BPI Labs LLC</LabelerName>
<SubstanceName>CARBOPLATIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Initial Treatment of Advanced Ovarian Carcinoma Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see CLINICAL STUDIES). There is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival (≥ 3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup. Secondary Treatment of Advanced Ovarian Carcinoma Carboplatin injection is indicated for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with cisplatin. Within the group of patients previously treated with cisplatin, those who have developed progressive disease while receiving cisplatin therapy may have a decreased response rate.</IndicationAndUsage>
<Description>Carboplatin injection,USP is supplied as a sterile, pyrogen-free, 10 mg/mL aqueous solution of carboplatin, USP. Carboplatin, USP is a platinum coordination compound. The chemical name for carboplatin, USP is platinum, diammine [1,1-cyclobutane dicarboxylato(2-)-0,0’]-,(SP-4-2), and carboplatin, USP has the following structural formula. C6H12N2O4Pt M.W. 371.25Carboplatin, USP is a crystalline powder. It is soluble in water at a rate of approximately 14 mg/mL, and the pH of a 1% solution is 5 to 7. It is virtually insoluble in ethanol, acetone, and dimethylacetamide.</Description>
</NDC>
<NDC>
<NDCCode>61649-165-15</NDCCode>
<PackageDescription>150 g in 1 TUBE (61649-165-15) </PackageDescription>
<NDC11Code>61649-0165-15</NDC11Code>
<ProductNDC>61649-165</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Attitude Oatmeal Sensitive Mineral Sunscreen Unscented Spf 30</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20231127</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>9055-7588 Quebec Inc. DBA Attitude</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-165-15</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (63776-165-15) </PackageDescription>
<NDC11Code>63776-0165-15</NDC11Code>
<ProductNDC>63776-165</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Foods</ProprietaryName>
<NonProprietaryName>Activated Charcoal, Ageratina Aromatica Root, Ferrous Iodide, Gelsemium Sempervirens Root, Calcium Sulfide, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Iodine, Potassium Gluconate, Lycopodium Clavatum Spore, Cajuput Oil, Black Currant, Rosa Canina Fruit, Serotonin, Xanthine, Almond, Apple, Banana, Barley, Bean, Beef, Cashew, Casein, Emmental Cultured, Casein, Lactococcus Lactis Cultured, Casein, Lactococcus Lactis Cultured Aged, Casein, Lactococcus Lactis Cultured</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ACTIVATED CHARCOAL; AGERATINA AROMATICA ROOT; ALMOND; APPLE; ARCHED SWIMMING CRAB, COOKED; BANANA; BARLEY; BEAN; BEEF; BLACK CURRANT; BLUE CRAB; BROWN RICE; CAJUPUT OIL; CALCIUM SULFIDE; CASEIN, EMMENTAL CULTURED; CASEIN, LACTOCOCCUS LACTIS CULTURED; CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED; CASHEW; CHICKEN; COCOA; COCONUT; COD, UNSPECIFIED; COFFEE BEAN; COTTON FIBER; COTTON SEED; COW MILK; DUNGENESS CRAB, COOKED; EGG; EGGPLANT; ENGLISH WALNUT; FERROUS IODIDE; FLAX SEED; GELSEMIUM SEMPERVIRENS ROOT; GREEN BELL PEPPER; HAZELNUT, UNSPECIFIED; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; IODINE; LAMB; LYCOPODIUM CLAVATUM SPORE; ONION; ORANGE; OYSTER, UNSPECIFIED; PEANUT; PECAN; PORK; POTASSIUM GLUCONATE; POTATO; ROSA CANINA FRUIT; SALMON, UNSPECIFIED; SEROTONIN; SERRATED SWIMMING CRAB, COOKED; SHRIMP, UNSPECIFIED; SNOW CRAB, UNSPECIFIED; SOYBEAN; STARCH, RICE; STRAWBERRY; TEA LEAF; TOMATO; TUNA, UNSPECIFIED; WHEAT; WHEAT GLUTEN; WHITE RICE; XANTHINE</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30; 1; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 1; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Egg Proteins, Dietary [CS], Fish Proteins, Dietary [EXT], Fish Proteins, Dietary [EXT], Fish Proteins, Dietary [EXT], Fruit Proteins [EXT], Fruit Proteins [EXT], Fruit Proteins [EXT], Fruit Proteins [EXT], Fruit Proteins [EXT], Grain Proteins [EXT], Grain Proteins [EXT], Grain Proteins [EXT], Grain Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63981-165-22</NDCCode>
<PackageDescription>15 BLISTER PACK in 1 CARTON (63981-165-22) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63981-0165-22</NDC11Code>
<ProductNDC>63981-165</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kirkland Signature Allerclear D 24hr</ProprietaryName>
<NonProprietaryName>Loratadine, Pseudoephedrine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070521</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075706</ApplicationNumber>
<LabelerName>Costco Wholesale Company</LabelerName>
<SubstanceName>PSEUDOEPHEDRINE SULFATE; LORATADINE</SubstanceName>
<StrengthNumber>240; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>64220-165-03</NDCCode>
<PackageDescription>15 kg in 1 CANISTER (64220-165-03) </PackageDescription>
<NDC11Code>64220-0165-03</NDC11Code>
<ProductNDC>64220-165</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20240804</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Zhejiang Huahai Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-08-07</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>04-AUG-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>64220-165-06</NDCCode>
<PackageDescription>15 kg in 1 DRUM (64220-165-06) </PackageDescription>
<NDC11Code>64220-0165-06</NDC11Code>
<ProductNDC>64220-165</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20240804</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Zhejiang Huahai Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-08-07</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>04-AUG-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>68546-490-42</NDCCode>
<PackageDescription>2 KIT in 1 BLISTER PACK (68546-490-42) / 1 KIT in 1 KIT * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-163-15) * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-165-15) * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-161-15) </PackageDescription>
<NDC11Code>68546-0490-42</NDC11Code>
<ProductNDC>68546-490</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Austedo Xr</ProprietaryName>
<NonProprietaryName>Deutetrabenazine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230221</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216354</ApplicationNumber>
<LabelerName>Teva Neuroscience, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230221</StartMarketingDatePackage>
<EndMarketingDatePackage>20250630</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>AUSTEDO XR® and AUSTEDO® are indicated in adults for the treatment of: 1 chorea associated with Huntington’s disease [see Clinical Studies (14.1)], 2 tardive dyskinesia [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>AUSTEDO XR extended-release tablets and AUSTEDO tablets are formulated with deutetrabenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor for oral administration. The molecular weight of deutetrabenazine is 323.46; the pKa is 6.31. Deutetrabenazine is a hexahydro-dimethoxybenzoquinolizine derivative and has the following chemical name: (RR, SS)-1, 3, 4, 6, 7, 11b-hexahydro-9, 10-di(methoxy-d3)-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one. The molecular formula for deutetrabenazine is C19H21D6NO3. Deutetrabenazine is a racemic mixture containing the following structures. Deutetrabenazine is a white to slightly yellow crystalline powder that is sparingly soluble in water and soluble in ethanol.AUSTEDO XR. AUSTEDO XR extended-release tablets contain 6 mg, 12 mg, 18 mg, 24 mg, 30 mg, 36 mg, 42 mg, or 48 mg deutetrabenazine, and the following inactive ingredients: ammonium hydroxide, black iron oxide, butyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, cellulose acetate, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, magnesium stearate, polyethylene glycol, polyethylene glycol 3350, polyethylene oxide, polyvinyl alcohol, propylene glycol, shellac, sodium chloride, talc, titanium dioxide, and FD&C red #40 lake. The 6 mg, 12 mg, 18 mg, 30 mg, 36 mg, and 42 mg extended-release tablets also contain FD&C yellow #6 lake. The 6 mg, 12 mg, 24 mg, and 36 mg extended-release tablets also contain FD&C blue #2 lake. The 18 mg extended-release tablets also contain carmine.AUSTEDO XR Delivery System Components and Performance AUSTEDO XR uses osmotic pressure to deliver deutetrabenazine at a controlled rate. The delivery system, which resembles a round tablet in appearance, consists of a bilayer core tablet that contains deutetrabenazine along with other excipients. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool. AUSTEDO. AUSTEDO tablets contain 6 mg, 9 mg, or 12 mg deutetrabenazine, and the following inactive ingredients: ammonium hydroxide, black iron oxide, butyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, polysorbate 80, polyvinyl alcohol, povidone, propylene glycol, shellac, talc, titanium dioxide, and FD&C blue #2 lake. The 6 mg tablets also contain FD&C red #40 lake. The 12 mg tablets also contain FD&C yellow #6 lake.</Description>
</NDC>
<NDC>
<NDCCode>68546-490-52</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (68546-490-52) / 1 KIT in 1 BLISTER PACK * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-163-15) * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-165-15) * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-161-15) </PackageDescription>
<NDC11Code>68546-0490-52</NDC11Code>
<ProductNDC>68546-490</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Austedo Xr</ProprietaryName>
<NonProprietaryName>Deutetrabenazine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230221</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216354</ApplicationNumber>
<LabelerName>Teva Neuroscience, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230221</StartMarketingDatePackage>
<EndMarketingDatePackage>20250630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AUSTEDO XR® and AUSTEDO® are indicated in adults for the treatment of: 1 chorea associated with Huntington’s disease [see Clinical Studies (14.1)], 2 tardive dyskinesia [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>AUSTEDO XR extended-release tablets and AUSTEDO tablets are formulated with deutetrabenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor for oral administration. The molecular weight of deutetrabenazine is 323.46; the pKa is 6.31. Deutetrabenazine is a hexahydro-dimethoxybenzoquinolizine derivative and has the following chemical name: (RR, SS)-1, 3, 4, 6, 7, 11b-hexahydro-9, 10-di(methoxy-d3)-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one. The molecular formula for deutetrabenazine is C19H21D6NO3. Deutetrabenazine is a racemic mixture containing the following structures. Deutetrabenazine is a white to slightly yellow crystalline powder that is sparingly soluble in water and soluble in ethanol.AUSTEDO XR. AUSTEDO XR extended-release tablets contain 6 mg, 12 mg, 18 mg, 24 mg, 30 mg, 36 mg, 42 mg, or 48 mg deutetrabenazine, and the following inactive ingredients: ammonium hydroxide, black iron oxide, butyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, cellulose acetate, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, magnesium stearate, polyethylene glycol, polyethylene glycol 3350, polyethylene oxide, polyvinyl alcohol, propylene glycol, shellac, sodium chloride, talc, titanium dioxide, and FD&C red #40 lake. The 6 mg, 12 mg, 18 mg, 30 mg, 36 mg, and 42 mg extended-release tablets also contain FD&C yellow #6 lake. The 6 mg, 12 mg, 24 mg, and 36 mg extended-release tablets also contain FD&C blue #2 lake. The 18 mg extended-release tablets also contain carmine.AUSTEDO XR Delivery System Components and Performance AUSTEDO XR uses osmotic pressure to deliver deutetrabenazine at a controlled rate. The delivery system, which resembles a round tablet in appearance, consists of a bilayer core tablet that contains deutetrabenazine along with other excipients. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool. AUSTEDO. AUSTEDO tablets contain 6 mg, 9 mg, or 12 mg deutetrabenazine, and the following inactive ingredients: ammonium hydroxide, black iron oxide, butyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, polysorbate 80, polyvinyl alcohol, povidone, propylene glycol, shellac, talc, titanium dioxide, and FD&C blue #2 lake. The 6 mg tablets also contain FD&C red #40 lake. The 12 mg tablets also contain FD&C yellow #6 lake.</Description>
</NDC>
<NDC>
<NDCCode>68682-399-15</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (68682-399-15) / 165 SPRAY, METERED in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>68682-0399-15</NDC11Code>
<ProductNDC>68682-399</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ipratropium Bromide</ProprietaryName>
<NonProprietaryName>Ipratropium Bromide</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20250601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076103</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>IPRATROPIUM BROMIDE</SubstanceName>
<StrengthNumber>42</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis. The safety and effectiveness of the use of Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) beyond four days in patients with the common cold or beyond three weeks in patients with seasonal allergic rhinitis has not been established.</IndicationAndUsage>
<Description>The active ingredient in Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) is ipratropium bromide monohydrate. It is an anticholinergic agent chemically described as 8-azoniabicyclo [3.2.1] octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide monohydrate, (3-endo,8-syn)-: a synthetic quaternary ammonium compound, chemically related to atropine. Its structural formula is: ipratropium bromide monohydrate. Ipratropium bromide is a white to off-white crystalline substance, freely soluble in water and methanol, sparingly soluble in ethanol, and insoluble in non-polar media. In aqueous solution, it exists in an ionized state as a quaternary ammonium compound. Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) is a metered-dose, manual pump spray unit which delivers 42 mcg ipratropium bromide (on an anhydrous basis) per spray (70 microliters) in an isotonic, aqueous solution, pH-adjusted to 4.7 with hydrochloric acid and/or sodium hydroxide (if needed). It also contains benzalkonium chloride, edetate disodium dihydrate, sodium chloride, and purified water. Each bottle contains 165 sprays.</Description>
</NDC>
<NDC>
<NDCCode>71919-165-07</NDCCode>
<PackageDescription>15 mL in 1 VIAL, GLASS (71919-165-07) </PackageDescription>
<NDC11Code>71919-0165-07</NDC11Code>
<ProductNDC>71919-165</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Carduus Benedictus</ProprietaryName>
<NonProprietaryName>Centaurea Benedicta</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121121</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>CENTAUREA BENEDICTA</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>85766-165-15</NDCCode>
<PackageDescription>1 CARTON in 1 CARTON (85766-165-15) / 15 mL in 1 CARTON</PackageDescription>
<NDC11Code>85766-0165-15</NDC11Code>
<ProductNDC>85766-165</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Goodsense Eye Drops Advanced Relief Moisturizer</ProprietaryName>
<NonProprietaryName>Dextran, Polyethylene Glycol 400, Povidone, Tetrahydrozoline Hcl</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20260207</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M018</ApplicationNumber>
<LabelerName>Sportpharm LLC</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 400; TETRAHYDROZOLINE HYDROCHLORIDE; POVIDONE; DEXTRAN 70</SubstanceName>
<StrengthNumber>1; .05; 1; .1</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Increased Intravascular Volume [PE], Osmotic Activity [MoA], Plasma Volume Expander [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 relieves redness of the eye due to minor eye irritations, 2 as a lubricant to prevent further irritation or to relieve dryness of the eye.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>85766-242-15</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (85766-242-15) / 165 SPRAY, METERED in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>85766-0242-15</NDC11Code>
<ProductNDC>85766-242</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ipratropium Bromide</ProprietaryName>
<NonProprietaryName>Ipratropium Bromide</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20250703</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217886</ApplicationNumber>
<LabelerName>Sportpharm LLC</LabelerName>
<SubstanceName>IPRATROPIUM BROMIDE</SubstanceName>
<StrengthNumber>42</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ipratropium bromide nasal solution, 0.06% is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. Ipratropium bromide 0.06% does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis. The safety and effectiveness of the use of ipratropium bromide 0.06% beyond four days in patients with the common cold or beyond three weeks in patients with seasonal allergic rhinitis has not been established.</IndicationAndUsage>
<Description>The active ingredient in ipratropium bromide nasal solution is ipratropium bromide, USP (as the monohydrate). It is an anticholinergic agent chemically described as 8-azoniabicyclo (3.2.1) octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate ( endo,syn)-, (±)-: a synthetic quaternary ammonium compound, chemically related to atropine. Its structural formula is:. Ipratropium bromide, USP is a white to off-white, crystalline powder. It is soluble in water, freely soluble in methanol and slightly soluble in ethanol (96%). Ipratropium bromide nasal solution, 0.06% is a metered-dose, manual pump spray unit which delivers 42 mcg ipratropium bromide, USP (on an anhydrous basis) per spray (70 mcL) in an isotonic, aqueous solution with pH-adjusted to 4.7 with hydrochloric acid and sodium hydroxide (if needed). It also contains benzalkonium chloride, edetate disodium, purified water and sodium chloride. Each bottle contains 165 metered sprays.</Description>
</NDC>
<NDC>
<NDCCode>0026-3950-50</NDCCode>
<PackageDescription>1 KIT in 1 BOX (0026-3950-50) * 5 mL in 1 VIAL (0026-4950-99) * 5 mL in 1 SYRINGE (0026-0426-05) * 5 mL in 1 VIAL, SINGLE-USE (0026-4950-01) * 5 mL in 1 SYRINGE (0026-0426-15) </PackageDescription>
<NDC11Code>00026-3950-50</NDC11Code>
<ProductNDC>0026-3950</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Jivi</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant) Pegylated-aucl</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20241202</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125661</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JIVI, is indicated for use in previously treated adults and pediatric patients 7 years of age and older with hemophilia A (congenital Factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes .</IndicationAndUsage>
<Description>JIVI [antihemophilic factor (recombinant), PEGylated-aucl] is a sterile, nonpyrogenic, preservative-free, white to slightly yellow lyophilized powder for reconstitution with sterile Water for Injection (sWFI) as diluent for intravenous (IV) administration. The product is supplied in single-dose vials containing dosage strengths of 500, 1000, 2000 and 3000 IU in 2.5 mL fill size and 4000 IU in 5 mL fill size. For each dosage strength, the actual assayed potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sWFI, prefilled diluent syringe. The 500, 1000, 2000, and 3000 IU vials of JIVI are formulated with the following excipients: 59 mg glycine, 27 mg sucrose, 8.4 mg histidine, 4.7 mg sodium chloride, 0.7 mg calcium chloride, and 0.216 mg polysorbate 80. The 4000 IU vial of Jivi is formulated with the following quantities of these excipients: 114 mg glycine, 52 mg sucrose, 16.1 mg histidine, 9.1 mg sodium chloride, 1.9 mg calcium chloride, and 0.416 mg polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. The specific activity of JIVI is approximately 10,000 IU/mg protein. The active protein (or starting molecule), prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells. JIVI is produced by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was selected for conjugation to provide both a consistent coagulation activity and high PEGylation efficiency. The molecular weight of JIVI is approximately 234 kDa based on the calculated average molecular weight of the BDD-rFVIII variant of 165 kDa, plus glycosylation (~4 kDa), and the average molecular weight of the PEG-maleimide of approximately 60 kDa. Functional characterization of JIVI shows comparable mechanism of action to that of rFVIII product with an extended plasma half-life [see Clinical Pharmacology (12.1)]. The manufacturing process of JIVI involves propagation of the recombinant production cell line with the harvest isolation process consisting of continuous filtration of tissue culture fluid and anion exchange chromatography on a membrane adsorber capsule. The process intermediate is purified from process- and product-related impurities using a series of chromatography and filtration steps, including 20 nm viral filtration, prior to conjugation to the 60 kDa maleimide PEG moiety. The mono-PEGylated JIVI active molecule is separated from product-related species by chromatography and then formulated by ultrafiltration. The cell culture, PEGylation, purification process and formulation used in the manufacture of JIVI do not use any additives of human or animal origins.</Description>
</NDC>
<NDC>
<NDCCode>0026-3950-99</NDCCode>
<PackageDescription>1 KIT in 1 BOX (0026-3950-99) * 5 mL in 1 VIAL (0026-4950-99) * 5 mL in 1 SYRINGE (0026-0426-05) * 5 mL in 1 VIAL, SINGLE-USE (0026-4950-01) * 5 mL in 1 SYRINGE (0026-0426-15) </PackageDescription>
<NDC11Code>00026-3950-99</NDC11Code>
<ProductNDC>0026-3950</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Jivi</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant) Pegylated-aucl</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20241202</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125661</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JIVI, is indicated for use in previously treated adults and pediatric patients 7 years of age and older with hemophilia A (congenital Factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes .</IndicationAndUsage>
<Description>JIVI [antihemophilic factor (recombinant), PEGylated-aucl] is a sterile, nonpyrogenic, preservative-free, white to slightly yellow lyophilized powder for reconstitution with sterile Water for Injection (sWFI) as diluent for intravenous (IV) administration. The product is supplied in single-dose vials containing dosage strengths of 500, 1000, 2000 and 3000 IU in 2.5 mL fill size and 4000 IU in 5 mL fill size. For each dosage strength, the actual assayed potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sWFI, prefilled diluent syringe. The 500, 1000, 2000, and 3000 IU vials of JIVI are formulated with the following excipients: 59 mg glycine, 27 mg sucrose, 8.4 mg histidine, 4.7 mg sodium chloride, 0.7 mg calcium chloride, and 0.216 mg polysorbate 80. The 4000 IU vial of Jivi is formulated with the following quantities of these excipients: 114 mg glycine, 52 mg sucrose, 16.1 mg histidine, 9.1 mg sodium chloride, 1.9 mg calcium chloride, and 0.416 mg polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. The specific activity of JIVI is approximately 10,000 IU/mg protein. The active protein (or starting molecule), prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells. JIVI is produced by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was selected for conjugation to provide both a consistent coagulation activity and high PEGylation efficiency. The molecular weight of JIVI is approximately 234 kDa based on the calculated average molecular weight of the BDD-rFVIII variant of 165 kDa, plus glycosylation (~4 kDa), and the average molecular weight of the PEG-maleimide of approximately 60 kDa. Functional characterization of JIVI shows comparable mechanism of action to that of rFVIII product with an extended plasma half-life [see Clinical Pharmacology (12.1)]. The manufacturing process of JIVI involves propagation of the recombinant production cell line with the harvest isolation process consisting of continuous filtration of tissue culture fluid and anion exchange chromatography on a membrane adsorber capsule. The process intermediate is purified from process- and product-related impurities using a series of chromatography and filtration steps, including 20 nm viral filtration, prior to conjugation to the 60 kDa maleimide PEG moiety. The mono-PEGylated JIVI active molecule is separated from product-related species by chromatography and then formulated by ultrafiltration. The cell culture, PEGylation, purification process and formulation used in the manufacture of JIVI do not use any additives of human or animal origins.</Description>
</NDC>
<NDC>
<NDCCode>0078-0569-12</NDCCode>
<PackageDescription>15 BLISTER PACK in 1 CARTON (0078-0569-12) / 1 KIT in 1 BLISTER PACK (0078-0569-61) * 3 mL in 1 VIAL, SINGLE-USE * 1.2 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00078-0569-12</NDC11Code>
<ProductNDC>0078-0569</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Extavia</ProprietaryName>
<NonProprietaryName>Interferon Beta-1b</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20090814</StartMarketingDate>
<EndMarketingDate>20240531</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125290</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090814</StartMarketingDatePackage>
<EndMarketingDatePackage>20240531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EXTAVIA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Interferon beta-1b is a purified, sterile, lyophilized protein product produced by recombinant DNA techniques. Interferon beta-1b is manufactured by bacterial fermentation of a strain of Escherichia coli that bears a genetically engineered plasmid containing the gene for human interferon betaser17. The native gene was obtained from human fibroblasts and altered in a way that substitutes serine for the cysteine residue found at position 17. Interferon beta-1b has 165 amino acids and an approximate molecular weight of 18,500 daltons. It does not include the carbohydrate side chains found in the natural material. The specific activity of EXTAVIA is approximately 32 million international units (IU)/mg interferon beta-1b. Each vial contains 0.3 mg of interferon beta-1b. The unit measurement is derived by comparing the antiviral activity of the product to the World Health Organization (WHO) reference standard of recombinant human interferon beta. Mannitol, USP and albumin (human), USP (15 mg each/vial) are added as stabilizers. EXTAVIA (interferon beta-1b) for injection is a sterile, preservative-free, white to off-white lyophilized powder, for subcutaneous injection after reconstitution with the diluent supplied (0.54% sodium chloride solution, USP). Each vial contains albumin (human), USP (15 mg), and mannitol, USP (15 mg).</Description>
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