{
"NDC": [
{
"NDCCode": "71334-230-13",
"PackageDescription": "1 KIT in 1 CARTON (71334-230-13) * 7 TABLET, FILM COATED in 1 BLISTER PACK (71334-215-07) * 7 TABLET, FILM COATED in 1 BLISTER PACK (71334-210-07) ",
"NDC11Code": "71334-0230-13",
"ProductNDC": "71334-230",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pyrukynd",
"NonProprietaryName": "Mitapivat",
"DosageFormName": "KIT",
"StartMarketingDate": "20220218",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216196",
"LabelerName": "Agios Pharmaceuticals, Inc.",
"Status": "Active",
"LastUpdate": "2026-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220218",
"SamplePackage": "N",
"IndicationAndUsage": "PYRUKYND is indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.",
"Description": "The active ingredient of PYRUKYND is mitapivat, a pyruvate kinase activator, present as mitapivat sulfate. The chemical name of mitapivat sulfate is 8-quinolinesulfonamide, N-[4-[[4- (cyclopropylmethyl)-1-piperazinyl]carbonyl]phenyl]-, sulfate, hydrate (2:1:3). The chemical structure of mitapivat sulfate is. The molecular formula is (C 24H 26N 4SO 3) 2 H 2SO 4 3H 2O, and the molecular weight is 1053.23 for mitapivat sulfate. Mitapivat sulfate is a white to off-white solid and is slightly soluble in water. PYRUKYND is available as 5 mg, 20 mg, and 50 mg tablets for oral administration. Each tablet contains 5 mg, 20 mg, or 50 mg mitapivat free base, provided as 5.85 mg, 23.4 mg, or 58.5 mg, respectively, of the sulfate hydrate salt, and the following inactive ingredients: croscarmellose sodium, mannitol, microcrystalline cellulose, and sodium stearyl fumarate. The tablet film coating contains the inactive ingredients FD&C Blue No. 2, hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The tablets are imprinted with black ink containing the inactive ingredients ammonium hydroxide, ferrosoferric oxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, and shellac glaze."
},
{
"NDCCode": "42241-002-13",
"PackageDescription": "230 L in 1 DEWAR (42241-002-13) ",
"NDC11Code": "42241-0002-13",
"ProductNDC": "42241-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrogen",
"NonProprietaryName": "Nitrogen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20111101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205766",
"LabelerName": "INDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC.",
"SubstanceName": "NITROGEN",
"StrengthNumber": "995",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111101",
"SamplePackage": "N"
},
{
"NDCCode": "51194-123-13",
"PackageDescription": "230 L in 1 DEWAR (51194-123-13) ",
"NDC11Code": "51194-0123-13",
"ProductNDC": "51194-123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20070522",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Calox Inc",
"SubstanceName": "OXYGEN",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070522",
"SamplePackage": "N"
},
{
"NDCCode": "52085-002-13",
"PackageDescription": "230 L in 1 DEWAR (52085-002-13) ",
"NDC11Code": "52085-0002-13",
"ProductNDC": "52085-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrogen",
"NonProprietaryName": "Nitrogen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20131201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205850",
"LabelerName": "ANALGESIC SERVICES, INC.",
"SubstanceName": "NITROGEN",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131201",
"SamplePackage": "N"
},
{
"NDCCode": "53329-230-13",
"PackageDescription": "59 mL in 1 BOTTLE (53329-230-13) ",
"NDC11Code": "53329-0230-13",
"ProductNDC": "53329-230",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medline",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260408",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Medline Industries, LP",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260408",
"SamplePackage": "N",
"IndicationAndUsage": "to decrease bacteria on the skin that could cause disease. recommended for repeated use. single use only (for 53329-230-02 packet packaging configuration only)."
},
{
"NDCCode": "55703-001-13",
"PackageDescription": "230 L in 1 DEWAR (55703-001-13) ",
"NDC11Code": "55703-0001-13",
"ProductNDC": "55703-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19990301",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Northwest Respiratory Services",
"SubstanceName": "OXYGEN",
"StrengthNumber": "992",
"StrengthUnit": "L/1000L",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19990301",
"SamplePackage": "N"
},
{
"NDCCode": "57664-230-13",
"PackageDescription": "500 TABLET in 1 BOTTLE (57664-230-13) ",
"NDC11Code": "57664-0230-13",
"ProductNDC": "57664-230",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130816",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090710",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130816",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults, 2 Narcolepsy.",
"Description": "Methylphenidate hydrochloride tablets contain methylphenidate hydrochloride, USP a CNS stimulant. It is available as tablets of 5 mg, 10 mg, and 20 mg strengths for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride, USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Each tablet contains 5 mg, 10 mg, or 20 mg of methylphenidate hydrochloride, USP. Inactive ingredients include: lactose monohydrate, magnesium stearate, polyethylene glycol 8000, and talc. In addition, the 5 mg tablet contains FD&C blue No. 2 aluminum lake and FD&C red No. 40 aluminum lake, the 10 mg tablet contains FD&C blue No. 2 aluminum lake and D&C yellow No. 10 aluminum lake and the 20 mg tablet contains FD&C yellow No. 6 aluminum lake."
},
{
"NDCCode": "63961-010-13",
"PackageDescription": "230 L in 1 DEWAR (63961-010-13) ",
"NDC11Code": "63961-0010-13",
"ProductNDC": "63961-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbon Dioxide",
"NonProprietaryName": "Carbon Dioxide",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20220110",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216614",
"LabelerName": "Middlesex Gases & Technologies, Inc.",
"SubstanceName": "CARBON DIOXIDE",
"StrengthNumber": "998",
"StrengthUnit": "mL/L",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20220110",
"SamplePackage": "N"
},
{
"NDCCode": "66694-001-13",
"PackageDescription": "230 L in 1 DEWAR (66694-001-13)",
"NDC11Code": "66694-0001-13",
"ProductNDC": "66694-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19360101",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Procaire, LLC",
"SubstanceName": "OXYGEN",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "68180-230-13",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (68180-230-13) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68180-230-11) ",
"NDC11Code": "68180-0230-13",
"ProductNDC": "68180-230",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150713",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090051",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150713",
"SamplePackage": "N"
},
{
"NDCCode": "70341-230-01",
"PackageDescription": "13 g in 1 CARTON (70341-230-01)",
"NDC11Code": "70341-0230-01",
"ProductNDC": "70341-230",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eco Soul Spau Bb Cushion 01 Light Beige",
"NonProprietaryName": "Titanium Dioxide, Octinoxate, Octisalate, Octocrylene, Zinc Oxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "The Saem International Co., Ltd.",
"SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE",
"StrengthNumber": "1.17; .91; .62; .26; .26",
"StrengthUnit": "g/13g; g/13g; g/13g; g/13g; g/13g",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "73962-002-13",
"PackageDescription": "230 mL in 1 BOTTLE, PUMP (73962-002-13) ",
"NDC11Code": "73962-0002-13",
"ProductNDC": "73962-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Zhejiang USHAS Cosmetics Co., Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "72",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N"
},
{
"NDCCode": "73962-004-13",
"PackageDescription": "230 mL in 1 BOTTLE, PUMP (73962-004-13) ",
"NDC11Code": "73962-0004-13",
"ProductNDC": "73962-004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"ProprietaryNameSuffix": "75%",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Zhejiang USHAS Cosmetics Co., Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N"
},
{
"NDCCode": "83602-230-13",
"PackageDescription": "13 BAG in 1 BOX (83602-230-13) / 1 PATCH in 1 BAG / 30 g in 1 PATCH",
"NDC11Code": "83602-0230-13",
"ProductNDC": "83602-230",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lidocaine Pain Relief Gel -patch",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260508",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": ".04",
"StrengthUnit": "g/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260508",
"SamplePackage": "N"
},
{
"NDCCode": "0310-0271-10",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0310-0271-10) ",
"NDC11Code": "00310-0271-10",
"ProductNDC": "0310-0271",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Seroquel",
"NonProprietaryName": "Quetiapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19971001",
"EndMarketingDate": "20270630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020639",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19971001",
"EndMarketingDatePackage": "20270630",
"SamplePackage": "N",
"IndicationAndUsage": "SEROQUEL is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "SEROQUEL® (quetiapine) is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. SEROQUEL is supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
},
{
"NDCCode": "0310-0272-10",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0310-0272-10) ",
"NDC11Code": "00310-0272-10",
"ProductNDC": "0310-0272",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Seroquel",
"NonProprietaryName": "Quetiapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19971001",
"EndMarketingDate": "20270630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020639",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19971001",
"EndMarketingDatePackage": "20270630",
"SamplePackage": "N",
"IndicationAndUsage": "SEROQUEL is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "SEROQUEL® (quetiapine) is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. SEROQUEL is supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
},
{
"NDCCode": "0310-0274-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (0310-0274-60) ",
"NDC11Code": "00310-0274-60",
"ProductNDC": "0310-0274",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Seroquel",
"NonProprietaryName": "Quetiapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20001113",
"EndMarketingDate": "20270430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020639",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20001113",
"EndMarketingDatePackage": "20270430",
"SamplePackage": "N",
"IndicationAndUsage": "SEROQUEL is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "SEROQUEL® (quetiapine) is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. SEROQUEL is supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
},
{
"NDCCode": "0310-0275-10",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0310-0275-10) ",
"NDC11Code": "00310-0275-10",
"ProductNDC": "0310-0275",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Seroquel",
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"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "QUETIAPINE FUMARATE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
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"IndicationAndUsage": "SEROQUEL is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "SEROQUEL® (quetiapine) is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. SEROQUEL is supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
},
{
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"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0310-0278-10) ",
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"ProductNDC": "0310-0278",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "SEROQUEL is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "SEROQUEL® (quetiapine) is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. SEROQUEL is supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
},
{
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"NDC11Code": "00310-0279-10",
"ProductNDC": "0310-0279",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Seroquel",
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"SubstanceName": "QUETIAPINE FUMARATE",
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"Pharm_Classes": "Atypical Antipsychotic [EPC]",
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"IndicationAndUsage": "SEROQUEL is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "SEROQUEL® (quetiapine) is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. SEROQUEL is supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
},
{
"NDCCode": "0310-0281-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0310-0281-60) ",
"NDC11Code": "00310-0281-60",
"ProductNDC": "0310-0281",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Seroquel",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Quetiapine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
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"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022047",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "QUETIAPINE FUMARATE",
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"Pharm_Classes": "Atypical Antipsychotic [EPC]",
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"IndicationAndUsage": "SEROQUEL XR is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder, manic, or mixed episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants (1.3).",
"Description": "SEROQUEL XR (quetiapine) is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f ] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. SEROQUEL XR is supplied for oral administration as 50 mg (peach), 150 mg (white), 200 mg (yellow), 300 mg (pale yellow), and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients for SEROQUEL XR are lactose monohydrate, microcrystalline cellulose, sodium citrate, hypromellose, and magnesium stearate. The film coating for all SEROQUEL XR tablets contain hypromellose, polyethylene glycol 400 and titanium dioxide. In addition, yellow iron oxide (50, 200 and 300 mg tablets) and red iron oxide (50 mg tablets) are included in the film coating of specific strengths. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
},
{
"NDCCode": "0310-0282-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0310-0282-60) ",
"NDC11Code": "00310-0282-60",
"ProductNDC": "0310-0282",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Seroquel",
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"NonProprietaryName": "Quetiapine",
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"SubstanceName": "QUETIAPINE FUMARATE",
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"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
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"IndicationAndUsage": "SEROQUEL XR is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder, manic, or mixed episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants (1.3).",
"Description": "SEROQUEL XR (quetiapine) is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f ] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. SEROQUEL XR is supplied for oral administration as 50 mg (peach), 150 mg (white), 200 mg (yellow), 300 mg (pale yellow), and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients for SEROQUEL XR are lactose monohydrate, microcrystalline cellulose, sodium citrate, hypromellose, and magnesium stearate. The film coating for all SEROQUEL XR tablets contain hypromellose, polyethylene glycol 400 and titanium dioxide. In addition, yellow iron oxide (50, 200 and 300 mg tablets) and red iron oxide (50 mg tablets) are included in the film coating of specific strengths. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
},
{
"NDCCode": "0310-0283-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0310-0283-60) ",
"NDC11Code": "00310-0283-60",
"ProductNDC": "0310-0283",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Seroquel",
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"IndicationAndUsage": "SEROQUEL XR is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder, manic, or mixed episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants (1.3).",
"Description": "SEROQUEL XR (quetiapine) is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f ] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. SEROQUEL XR is supplied for oral administration as 50 mg (peach), 150 mg (white), 200 mg (yellow), 300 mg (pale yellow), and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients for SEROQUEL XR are lactose monohydrate, microcrystalline cellulose, sodium citrate, hypromellose, and magnesium stearate. The film coating for all SEROQUEL XR tablets contain hypromellose, polyethylene glycol 400 and titanium dioxide. In addition, yellow iron oxide (50, 200 and 300 mg tablets) and red iron oxide (50 mg tablets) are included in the film coating of specific strengths. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
},
{
"NDCCode": "0310-0284-60",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Seroquel",
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"IndicationAndUsage": "SEROQUEL XR is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder, manic, or mixed episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants (1.3).",
"Description": "SEROQUEL XR (quetiapine) is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f ] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. SEROQUEL XR is supplied for oral administration as 50 mg (peach), 150 mg (white), 200 mg (yellow), 300 mg (pale yellow), and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients for SEROQUEL XR are lactose monohydrate, microcrystalline cellulose, sodium citrate, hypromellose, and magnesium stearate. The film coating for all SEROQUEL XR tablets contain hypromellose, polyethylene glycol 400 and titanium dioxide. In addition, yellow iron oxide (50, 200 and 300 mg tablets) and red iron oxide (50 mg tablets) are included in the film coating of specific strengths. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
},
{
"NDCCode": "0615-8470-05",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
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"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
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"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "QUETIAPINE FUMARATE",
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"IndicationAndUsage": "Quetiapine tablets, USP are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "Quetiapine fumarate, USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate, USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are lactose, microcrystalline cellulose, sodium starch glycolate, corn starch, dibasic calcium phosphate dihydrate, talc, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain iron oxide red and iron oxide yellow and the 100 mg and 400 mg tablets contain only iron oxide yellow. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.53 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
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"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "QUETIAPINE FUMARATE",
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"Status": "Active",
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"IndicationAndUsage": "Quetiapine tablets, USP are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "Quetiapine fumarate, USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate, USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are lactose, microcrystalline cellulose, sodium starch glycolate, corn starch, dibasic calcium phosphate dihydrate, talc, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain iron oxide red and iron oxide yellow and the 100 mg and 400 mg tablets contain only iron oxide yellow. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.53 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
},
{
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"PackageDescription": "6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8470-30) / 5 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00615-8470-30",
"ProductNDC": "0615-8470",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202674",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "QUETIAPINE FUMARATE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-02-01",
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"StartMarketingDatePackage": "20230510",
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"IndicationAndUsage": "Quetiapine tablets, USP are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "Quetiapine fumarate, USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate, USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are lactose, microcrystalline cellulose, sodium starch glycolate, corn starch, dibasic calcium phosphate dihydrate, talc, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain iron oxide red and iron oxide yellow and the 100 mg and 400 mg tablets contain only iron oxide yellow. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.53 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
},
{
"NDCCode": "0615-8470-39",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8470-39) ",
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"ProductNDC": "0615-8470",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202674",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
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"StartMarketingDatePackage": "20230509",
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"IndicationAndUsage": "Quetiapine tablets, USP are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "Quetiapine fumarate, USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate, USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are lactose, microcrystalline cellulose, sodium starch glycolate, corn starch, dibasic calcium phosphate dihydrate, talc, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain iron oxide red and iron oxide yellow and the 100 mg and 400 mg tablets contain only iron oxide yellow. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.53 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
},
{
"NDCCode": "0615-8471-05",
"PackageDescription": "15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8471-05) ",
"NDC11Code": "00615-8471-05",
"ProductNDC": "0615-8471",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202674",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "QUETIAPINE FUMARATE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
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"LastUpdate": "2025-02-28",
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"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "Quetiapine tablets, USP are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "Quetiapine fumarate, USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate, USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are lactose, microcrystalline cellulose, sodium starch glycolate, corn starch, dibasic calcium phosphate dihydrate, talc, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain iron oxide red and iron oxide yellow and the 100 mg and 400 mg tablets contain only iron oxide yellow. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.53 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
},
{
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"NDC11Code": "00615-8471-28",
"ProductNDC": "0615-8471",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202674",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
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"StartMarketingDatePackage": "20240506",
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"IndicationAndUsage": "Quetiapine tablets, USP are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "Quetiapine fumarate, USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate, USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are lactose, microcrystalline cellulose, sodium starch glycolate, corn starch, dibasic calcium phosphate dihydrate, talc, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain iron oxide red and iron oxide yellow and the 100 mg and 400 mg tablets contain only iron oxide yellow. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.53 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
}
]
}
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<PackageDescription>1 KIT in 1 CARTON (71334-230-13) * 7 TABLET, FILM COATED in 1 BLISTER PACK (71334-215-07) * 7 TABLET, FILM COATED in 1 BLISTER PACK (71334-210-07) </PackageDescription>
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<IndicationAndUsage>PYRUKYND is indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.</IndicationAndUsage>
<Description>The active ingredient of PYRUKYND is mitapivat, a pyruvate kinase activator, present as mitapivat sulfate. The chemical name of mitapivat sulfate is 8-quinolinesulfonamide, N-[4-[[4- (cyclopropylmethyl)-1-piperazinyl]carbonyl]phenyl]-, sulfate, hydrate (2:1:3). The chemical structure of mitapivat sulfate is. The molecular formula is (C 24H 26N 4SO 3) 2 H 2SO 4 3H 2O, and the molecular weight is 1053.23 for mitapivat sulfate. Mitapivat sulfate is a white to off-white solid and is slightly soluble in water. PYRUKYND is available as 5 mg, 20 mg, and 50 mg tablets for oral administration. Each tablet contains 5 mg, 20 mg, or 50 mg mitapivat free base, provided as 5.85 mg, 23.4 mg, or 58.5 mg, respectively, of the sulfate hydrate salt, and the following inactive ingredients: croscarmellose sodium, mannitol, microcrystalline cellulose, and sodium stearyl fumarate. The tablet film coating contains the inactive ingredients FD&C Blue No. 2, hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The tablets are imprinted with black ink containing the inactive ingredients ammonium hydroxide, ferrosoferric oxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, and shellac glaze.</Description>
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<PackageDescription>230 L in 1 DEWAR (42241-002-13) </PackageDescription>
<NDC11Code>42241-0002-13</NDC11Code>
<ProductNDC>42241-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrogen</ProprietaryName>
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<RouteName>RESPIRATORY (INHALATION)</RouteName>
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<LabelerName>INDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC.</LabelerName>
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<SamplePackage>N</SamplePackage>
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<ProductNDC>51194-123</ProductNDC>
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<LabelerName>Calox Inc</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<PackageDescription>230 L in 1 DEWAR (52085-002-13) </PackageDescription>
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<ProductNDC>52085-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205850</ApplicationNumber>
<LabelerName>ANALGESIC SERVICES, INC.</LabelerName>
<SubstanceName>NITROGEN</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>53329-230-13</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE (53329-230-13) </PackageDescription>
<NDC11Code>53329-0230-13</NDC11Code>
<ProductNDC>53329-230</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Medline</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Medline Industries, LP</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260408</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to decrease bacteria on the skin that could cause disease. recommended for repeated use. single use only (for 53329-230-02 packet packaging configuration only).</IndicationAndUsage>
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<NDC>
<NDCCode>55703-001-13</NDCCode>
<PackageDescription>230 L in 1 DEWAR (55703-001-13) </PackageDescription>
<NDC11Code>55703-0001-13</NDC11Code>
<ProductNDC>55703-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
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<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19990301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Northwest Respiratory Services</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>992</StrengthNumber>
<StrengthUnit>L/1000L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDCCode>57664-230-13</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (57664-230-13) </PackageDescription>
<NDC11Code>57664-0230-13</NDC11Code>
<ProductNDC>57664-230</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130816</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090710</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults, 2 Narcolepsy.</IndicationAndUsage>
<Description>Methylphenidate hydrochloride tablets contain methylphenidate hydrochloride, USP a CNS stimulant. It is available as tablets of 5 mg, 10 mg, and 20 mg strengths for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride, USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Each tablet contains 5 mg, 10 mg, or 20 mg of methylphenidate hydrochloride, USP. Inactive ingredients include: lactose monohydrate, magnesium stearate, polyethylene glycol 8000, and talc. In addition, the 5 mg tablet contains FD&C blue No. 2 aluminum lake and FD&C red No. 40 aluminum lake, the 10 mg tablet contains FD&C blue No. 2 aluminum lake and D&C yellow No. 10 aluminum lake and the 20 mg tablet contains FD&C yellow No. 6 aluminum lake.</Description>
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<NDC>
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<PackageDescription>230 L in 1 DEWAR (63961-010-13) </PackageDescription>
<NDC11Code>63961-0010-13</NDC11Code>
<ProductNDC>63961-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbon Dioxide</ProprietaryName>
<NonProprietaryName>Carbon Dioxide</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20220110</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216614</ApplicationNumber>
<LabelerName>Middlesex Gases & Technologies, Inc.</LabelerName>
<SubstanceName>CARBON DIOXIDE</SubstanceName>
<StrengthNumber>998</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66694-001-13</NDCCode>
<PackageDescription>230 L in 1 DEWAR (66694-001-13)</PackageDescription>
<NDC11Code>66694-0001-13</NDC11Code>
<ProductNDC>66694-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19360101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Procaire, LLC</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68180-230-13</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (68180-230-13) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68180-230-11) </PackageDescription>
<NDC11Code>68180-0230-13</NDC11Code>
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<IndicationAndUsage>SEROQUEL is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>SEROQUEL® (quetiapine) is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. SEROQUEL is supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
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<IndicationAndUsage>SEROQUEL is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>SEROQUEL® (quetiapine) is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. SEROQUEL is supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
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<IndicationAndUsage>SEROQUEL is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>SEROQUEL® (quetiapine) is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. SEROQUEL is supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
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<IndicationAndUsage>SEROQUEL is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>SEROQUEL® (quetiapine) is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. SEROQUEL is supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
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<IndicationAndUsage>SEROQUEL is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>SEROQUEL® (quetiapine) is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. SEROQUEL is supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
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<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
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<IndicationAndUsage>SEROQUEL is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>SEROQUEL® (quetiapine) is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. SEROQUEL is supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
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<Description>SEROQUEL XR (quetiapine) is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f ] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. SEROQUEL XR is supplied for oral administration as 50 mg (peach), 150 mg (white), 200 mg (yellow), 300 mg (pale yellow), and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients for SEROQUEL XR are lactose monohydrate, microcrystalline cellulose, sodium citrate, hypromellose, and magnesium stearate. The film coating for all SEROQUEL XR tablets contain hypromellose, polyethylene glycol 400 and titanium dioxide. In addition, yellow iron oxide (50, 200 and 300 mg tablets) and red iron oxide (50 mg tablets) are included in the film coating of specific strengths. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
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<Description>SEROQUEL XR (quetiapine) is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f ] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. SEROQUEL XR is supplied for oral administration as 50 mg (peach), 150 mg (white), 200 mg (yellow), 300 mg (pale yellow), and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients for SEROQUEL XR are lactose monohydrate, microcrystalline cellulose, sodium citrate, hypromellose, and magnesium stearate. The film coating for all SEROQUEL XR tablets contain hypromellose, polyethylene glycol 400 and titanium dioxide. In addition, yellow iron oxide (50, 200 and 300 mg tablets) and red iron oxide (50 mg tablets) are included in the film coating of specific strengths. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
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<Description>SEROQUEL XR (quetiapine) is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f ] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. SEROQUEL XR is supplied for oral administration as 50 mg (peach), 150 mg (white), 200 mg (yellow), 300 mg (pale yellow), and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients for SEROQUEL XR are lactose monohydrate, microcrystalline cellulose, sodium citrate, hypromellose, and magnesium stearate. The film coating for all SEROQUEL XR tablets contain hypromellose, polyethylene glycol 400 and titanium dioxide. In addition, yellow iron oxide (50, 200 and 300 mg tablets) and red iron oxide (50 mg tablets) are included in the film coating of specific strengths. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
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<Description>SEROQUEL XR (quetiapine) is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f ] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. SEROQUEL XR is supplied for oral administration as 50 mg (peach), 150 mg (white), 200 mg (yellow), 300 mg (pale yellow), and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients for SEROQUEL XR are lactose monohydrate, microcrystalline cellulose, sodium citrate, hypromellose, and magnesium stearate. The film coating for all SEROQUEL XR tablets contain hypromellose, polyethylene glycol 400 and titanium dioxide. In addition, yellow iron oxide (50, 200 and 300 mg tablets) and red iron oxide (50 mg tablets) are included in the film coating of specific strengths. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
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<Description>Quetiapine fumarate, USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate, USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are lactose, microcrystalline cellulose, sodium starch glycolate, corn starch, dibasic calcium phosphate dihydrate, talc, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain iron oxide red and iron oxide yellow and the 100 mg and 400 mg tablets contain only iron oxide yellow. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.53 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
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<Description>Quetiapine fumarate, USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate, USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are lactose, microcrystalline cellulose, sodium starch glycolate, corn starch, dibasic calcium phosphate dihydrate, talc, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain iron oxide red and iron oxide yellow and the 100 mg and 400 mg tablets contain only iron oxide yellow. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.53 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
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<Description>Quetiapine fumarate, USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate, USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are lactose, microcrystalline cellulose, sodium starch glycolate, corn starch, dibasic calcium phosphate dihydrate, talc, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain iron oxide red and iron oxide yellow and the 100 mg and 400 mg tablets contain only iron oxide yellow. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.53 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
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<Description>Quetiapine fumarate, USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate, USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are lactose, microcrystalline cellulose, sodium starch glycolate, corn starch, dibasic calcium phosphate dihydrate, talc, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain iron oxide red and iron oxide yellow and the 100 mg and 400 mg tablets contain only iron oxide yellow. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.53 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
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<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202674</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230509</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine tablets, USP are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>Quetiapine fumarate, USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate, USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are lactose, microcrystalline cellulose, sodium starch glycolate, corn starch, dibasic calcium phosphate dihydrate, talc, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain iron oxide red and iron oxide yellow and the 100 mg and 400 mg tablets contain only iron oxide yellow. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.53 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
</NDC>
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<NDCCode>0615-8471-28</NDCCode>
<PackageDescription>28 TABLET, FILM COATED in 1 BLISTER PACK (0615-8471-28) </PackageDescription>
<NDC11Code>00615-8471-28</NDC11Code>
<ProductNDC>0615-8471</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202674</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine tablets, USP are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>Quetiapine fumarate, USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate, USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are lactose, microcrystalline cellulose, sodium starch glycolate, corn starch, dibasic calcium phosphate dihydrate, talc, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain iron oxide red and iron oxide yellow and the 100 mg and 400 mg tablets contain only iron oxide yellow. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.53 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
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