{
"NDC": [
{
"NDCCode": "15631-0457-4",
"PackageDescription": "2500 PELLET in 1 PACKAGE (15631-0457-4) ",
"NDC11Code": "15631-0457-04",
"ProductNDC": "15631-0457",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Verbascum Thapsus",
"NonProprietaryName": "Verbascum Thapsus",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151031",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "VERBASCUM THAPSUS",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "15631-0457-0",
"PackageDescription": "100 PELLET in 1 VIAL, SINGLE-DOSE (15631-0457-0) ",
"NDC11Code": "15631-0457-00",
"ProductNDC": "15631-0457",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Verbascum Thapsus",
"NonProprietaryName": "Verbascum Thapsus",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151031",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "VERBASCUM THAPSUS",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "15631-0457-1",
"PackageDescription": "200 PELLET in 1 PACKAGE (15631-0457-1) ",
"NDC11Code": "15631-0457-01",
"ProductNDC": "15631-0457",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Verbascum Thapsus",
"NonProprietaryName": "Verbascum Thapsus",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151031",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "VERBASCUM THAPSUS",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "15631-0457-2",
"PackageDescription": "400 PELLET in 1 PACKAGE (15631-0457-2) ",
"NDC11Code": "15631-0457-02",
"ProductNDC": "15631-0457",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Verbascum Thapsus",
"NonProprietaryName": "Verbascum Thapsus",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151031",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "VERBASCUM THAPSUS",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "15631-0457-3",
"PackageDescription": "750 PELLET in 1 PACKAGE (15631-0457-3) ",
"NDC11Code": "15631-0457-03",
"ProductNDC": "15631-0457",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Verbascum Thapsus",
"NonProprietaryName": "Verbascum Thapsus",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151031",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "VERBASCUM THAPSUS",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "15631-0457-5",
"PackageDescription": "12500 PELLET in 1 PACKAGE (15631-0457-5) ",
"NDC11Code": "15631-0457-05",
"ProductNDC": "15631-0457",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Verbascum Thapsus",
"NonProprietaryName": "Verbascum Thapsus",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151031",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "VERBASCUM THAPSUS",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "12658-0457-1",
"PackageDescription": "4 kg in 1 DRUM (12658-0457-1) ",
"NDC11Code": "12658-0457-01",
"ProductNDC": "12658-0457",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Acetazolamide",
"DosageFormName": "POWDER",
"StartMarketingDate": "19820101",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "ZAKLADY FARMACEUTYCZNE POLPHARMA S A",
"SubstanceName": "ACETAZOLAMIDE",
"StrengthNumber": "4",
"StrengthUnit": "kg/4kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "01-JAN-82"
},
{
"NDCCode": "17856-0457-3",
"PackageDescription": "72 POUCH in 1 CASE (17856-0457-3) > 4 g in 1 POUCH",
"NDC11Code": "17856-0457-03",
"ProductNDC": "17856-0457",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Polyethylene Glycol 3350",
"NonProprietaryName": "Polyethylene Glycol 3350",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20060906",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077706",
"LabelerName": "Atlantic Biologicals Corps",
"SubstanceName": "POLYETHYLENE GLYCOL 3350",
"StrengthNumber": "17",
"StrengthUnit": "g/17g",
"Pharm_Classes": "Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180301",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of occasional constipation. This product should be used for 2 weeks or less or as directed by a physician.",
"Description": "A white powder for reconstitution. Polyethylene Glycol 3350 NF (Polyethylene Glycol 3350 Powder For Oral Solution) is a synthetic polyglycol having an average molecular weight of 3350. The actual molecular weight is not less than 90.0 percent and not greater than 110.0 percent of the nominal value. The chemical formula is HO(C2H4O)nH in which n represents the average number of oxyethylene groups. Below 55°C it is a free flowing white powder freely soluble in water. Polyethylene Glycol 3350 NF is an osmotic agent for the treatment of constipation."
},
{
"NDCCode": "17856-0457-4",
"PackageDescription": "72 POUCH in 1 CASE (17856-0457-4) > 4.25 g in 1 POUCH",
"NDC11Code": "17856-0457-04",
"ProductNDC": "17856-0457",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Polyethylene Glycol 3350",
"NonProprietaryName": "Polyethylene Glycol 3350",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20060906",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077706",
"LabelerName": "Atlantic Biologicals Corps",
"SubstanceName": "POLYETHYLENE GLYCOL 3350",
"StrengthNumber": "17",
"StrengthUnit": "g/17g",
"Pharm_Classes": "Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180301",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of occasional constipation. This product should be used for 2 weeks or less or as directed by a physician.",
"Description": "A white powder for reconstitution. Polyethylene Glycol 3350 NF (Polyethylene Glycol 3350 Powder For Oral Solution) is a synthetic polyglycol having an average molecular weight of 3350. The actual molecular weight is not less than 90.0 percent and not greater than 110.0 percent of the nominal value. The chemical formula is HO(C2H4O)nH in which n represents the average number of oxyethylene groups. Below 55°C it is a free flowing white powder freely soluble in water. Polyethylene Glycol 3350 NF is an osmotic agent for the treatment of constipation."
},
{
"NDCCode": "49288-0457-4",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0457-4)",
"NDC11Code": "49288-0457-04",
"ProductNDC": "49288-0457",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sage Mixture",
"NonProprietaryName": "Sage Mixture",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "ARTEMISIA VULGARIS POLLEN; ARTEMISIA ABSINTHIUM POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA LUDOVICIANA POLLEN",
"StrengthNumber": ".0125; .0125; .0125; .0125",
"StrengthUnit": "g/mL; g/mL; g/mL; g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
},
{
"NDCCode": "50090-0457-4",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (50090-0457-4) ",
"NDC11Code": "50090-0457-04",
"ProductNDC": "50090-0457",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Piroxicam",
"NonProprietaryName": "Piroxicam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074118",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "PIROXICAM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20160629",
"SamplePackage": "N"
},
{
"NDCCode": "51552-0457-4",
"PackageDescription": "25 g in 1 CONTAINER (51552-0457-4) ",
"NDC11Code": "51552-0457-04",
"ProductNDC": "51552-0457",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Pirpxicam",
"DosageFormName": "POWDER",
"StartMarketingDate": "19980401",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "PIROXICAM",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "01-APR-98"
},
{
"NDCCode": "58443-0457-4",
"PackageDescription": "237 mL in 1 BOTTLE (58443-0457-4) ",
"NDC11Code": "58443-0457-04",
"ProductNDC": "58443-0457",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Australian Gold",
"ProprietaryNameSuffix": "Broad Spectrum Spf 4",
"NonProprietaryName": "Avobenzone, Octocrylene",
"DosageFormName": "OIL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201222",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Prime Enterprises, Inc.",
"SubstanceName": "AVOBENZONE; OCTOCRYLENE",
"StrengthNumber": "9.02; 9.02",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20201222",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn."
},
{
"NDCCode": "71335-0457-4",
"PackageDescription": "90 TABLET, COATED in 1 BOTTLE (71335-0457-4) ",
"NDC11Code": "71335-0457-04",
"ProductNDC": "71335-0457",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benazepril Hydrochloride",
"NonProprietaryName": "Benazepril Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076118",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]",
"Status": "Active",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220209",
"SamplePackage": "N",
"IndicationAndUsage": "Benazepril hydrochloride tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in Black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with thiazide diuretics.",
"Description": "Benazepril hydrochloride, USP is a white to off-white crystalline powder, soluble (> 100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is benazepril 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C24H28N2O5HCl and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril hydrochloride is supplied as film-coated tablets containing 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are carnauba wax, colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide, and triacetin. The 10 mg tablet also contains FD&C Red No. 40 aluminum lake. The 20 mg tablet also contains black iron oxide and yellow iron oxide. The 40 mg tablet also contains FD&C Blue No. 2 aluminum lake. Benazepril hydrochloride tablets USP, 5 mg, 10 mg, 20 mg and 40 mg meet USP Dissolution Test 2."
},
{
"NDCCode": "0078-0457-05",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0078-0457-05) ",
"NDC11Code": "00078-0457-05",
"ProductNDC": "0078-0457",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trileptal",
"NonProprietaryName": "Oxcarbazepine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20000130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021014",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "OXCARBAZEPINE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20000130",
"SamplePackage": "N",
"IndicationAndUsage": "TRILEPTAL is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.",
"Description": "TRILEPTAL is an AED available as 150 mg, 300 mg, and 600 mg film-coated tablets for oral administration. TRILEPTAL is also available as a 300 mg/5 mL (60 mg/mL) oral suspension. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is a white to faintly orange crystalline powder. It is slightly soluble in chloroform, dichloromethane, acetone, and methanol and practically insoluble in ethanol, ether and water. Its molecular weight is 252.27 g/mol. TRILEPTAL film-coated tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide. TRILEPTAL oral suspension contains the following inactive ingredients: ascorbic acid; dispersible cellulose; ethanol; macrogol stearate; methyl parahydroxybenzoate; propylene glycol; propyl parahydroxybenzoate; purified water; sodium saccharin; sorbic acid; sorbitol; yellow-plum-lemon aroma."
},
{
"NDCCode": "0078-0457-35",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0457-35) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0078-0457-61) ",
"NDC11Code": "00078-0457-35",
"ProductNDC": "0078-0457",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trileptal",
"NonProprietaryName": "Oxcarbazepine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20000130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021014",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "OXCARBAZEPINE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20000130",
"SamplePackage": "N",
"IndicationAndUsage": "TRILEPTAL is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.",
"Description": "TRILEPTAL is an AED available as 150 mg, 300 mg, and 600 mg film-coated tablets for oral administration. TRILEPTAL is also available as a 300 mg/5 mL (60 mg/mL) oral suspension. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is a white to faintly orange crystalline powder. It is slightly soluble in chloroform, dichloromethane, acetone, and methanol and practically insoluble in ethanol, ether and water. Its molecular weight is 252.27 g/mol. TRILEPTAL film-coated tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide. TRILEPTAL oral suspension contains the following inactive ingredients: ascorbic acid; dispersible cellulose; ethanol; macrogol stearate; methyl parahydroxybenzoate; propylene glycol; propyl parahydroxybenzoate; purified water; sodium saccharin; sorbic acid; sorbitol; yellow-plum-lemon aroma."
},
{
"NDCCode": "0168-0457-04",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0457-04) > 120 g in 1 TUBE",
"NDC11Code": "00168-0457-04",
"ProductNDC": "0168-0457",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140714",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200735",
"LabelerName": "Fougera Pharmaceuticals Inc.",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140714",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinonide cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older (1). Limitation of Use: : 1 Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis (1). , 2 Avoid use on the face, groin, or axillae (1.2). , 3 Avoid use in perioral dermatitis or rosacea. .",
"Description": "Fluocinonide cream USP, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.58. It has the following chemical structure:. Fluocinonide is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol. Each gram of fluocinonide cream USP, 0.1% contains 1 mg fluocinonide in a cream base of propylene glycol USP, diethylene glycol monoethyl ether NF, glyceryl stearate (and) PEG-100 stearate, purified water USP, glyceryl monostearate NF, white petrolatum USP, carbomer 980 NF, diisopropanolamine, and citric acid USP."
},
{
"NDCCode": "0168-0457-30",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0457-30) > 30 g in 1 TUBE",
"NDC11Code": "00168-0457-30",
"ProductNDC": "0168-0457",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140714",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200735",
"LabelerName": "Fougera Pharmaceuticals Inc.",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140714",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinonide cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older (1). Limitation of Use: : 1 Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis (1). , 2 Avoid use on the face, groin, or axillae (1.2). , 3 Avoid use in perioral dermatitis or rosacea. .",
"Description": "Fluocinonide cream USP, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.58. It has the following chemical structure:. Fluocinonide is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol. Each gram of fluocinonide cream USP, 0.1% contains 1 mg fluocinonide in a cream base of propylene glycol USP, diethylene glycol monoethyl ether NF, glyceryl stearate (and) PEG-100 stearate, purified water USP, glyceryl monostearate NF, white petrolatum USP, carbomer 980 NF, diisopropanolamine, and citric acid USP."
},
{
"NDCCode": "0168-0457-60",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0457-60) > 60 g in 1 TUBE",
"NDC11Code": "00168-0457-60",
"ProductNDC": "0168-0457",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140714",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200735",
"LabelerName": "Fougera Pharmaceuticals Inc.",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140714",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinonide cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older (1). Limitation of Use: : 1 Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis (1). , 2 Avoid use on the face, groin, or axillae (1.2). , 3 Avoid use in perioral dermatitis or rosacea. .",
"Description": "Fluocinonide cream USP, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.58. It has the following chemical structure:. Fluocinonide is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol. Each gram of fluocinonide cream USP, 0.1% contains 1 mg fluocinonide in a cream base of propylene glycol USP, diethylene glycol monoethyl ether NF, glyceryl stearate (and) PEG-100 stearate, purified water USP, glyceryl monostearate NF, white petrolatum USP, carbomer 980 NF, diisopropanolamine, and citric acid USP."
},
{
"NDCCode": "10812-457-01",
"PackageDescription": "1 APPLICATOR in 1 BLISTER PACK (10812-457-01) > 4.9 g in 1 APPLICATOR",
"NDC11Code": "10812-0457-01",
"ProductNDC": "10812-457",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Healthy Skin Brightening Eye Perfector",
"ProprietaryNameSuffix": "Sunscreen Broad Spectrum Spf25 - Light 10",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130524",
"EndMarketingDate": "20181201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "18.8",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2018-12-04",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "11410-457-10",
"PackageDescription": "1 TUBE in 1 BOX (11410-457-10) / 177.4 mL in 1 TUBE",
"NDC11Code": "11410-0457-10",
"ProductNDC": "11410-457",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Proactiv Clean Mineral Acne Cleanser",
"NonProprietaryName": "Sulfur",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220815",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "Alchemee, LLC",
"SubstanceName": "SULFUR",
"StrengthNumber": "3",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220815",
"SamplePackage": "N",
"IndicationAndUsage": "for the management of acne."
},
{
"NDCCode": "11822-0457-0",
"PackageDescription": "1 BOTTLE in 1 CARTON (11822-0457-0) > 25 CAPSULE, LIQUID FILLED in 1 BOTTLE",
"NDC11Code": "11822-0457-00",
"ProductNDC": "11822-0457",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20201130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207235",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201203",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "11822-0457-1",
"PackageDescription": "1 BOTTLE in 1 CARTON (11822-0457-1) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE",
"NDC11Code": "11822-0457-01",
"ProductNDC": "11822-0457",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20201130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207235",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201130",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "14141-457-01",
"PackageDescription": "4 g in 1 CARTON (14141-457-01) ",
"NDC11Code": "14141-0457-01",
"ProductNDC": "14141-457",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ultra Balm Moisturizing Protective Balm For Lips Spf 20 Nude Caramel",
"NonProprietaryName": "Octinoxate, Zinc Oxide",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210616",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "BEL STAR S A",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "7.5; 4.9",
"StrengthUnit": "g/100g; g/100g",
"Status": "Active",
"LastUpdate": "2025-06-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210616",
"SamplePackage": "N",
"IndicationAndUsage": "Stop use and ask a doctor ifrash occurs."
},
{
"NDCCode": "16590-457-15",
"PackageDescription": "15 TABLET in 1 BOTTLE (16590-457-15)",
"NDC11Code": "16590-0457-15",
"ProductNDC": "16590-457",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077397",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Major Depressive Disorder– Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Premenstrual Dysphoric Disorder (PMDD) – Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-IIIR/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol and sparingly soluble in ethanol. Sertraline hydrochloride is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, Polysorbate 80, D&C Yellow # 10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue # 2/Indigo Carmine Aluminum Lake and Polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, Polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100mg tablet) and sodium starch glycolate."
},
{
"NDCCode": "16590-457-28",
"PackageDescription": "28 TABLET in 1 BOTTLE (16590-457-28)",
"NDC11Code": "16590-0457-28",
"ProductNDC": "16590-457",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077397",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Major Depressive Disorder– Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Premenstrual Dysphoric Disorder (PMDD) – Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-IIIR/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol and sparingly soluble in ethanol. Sertraline hydrochloride is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, Polysorbate 80, D&C Yellow # 10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue # 2/Indigo Carmine Aluminum Lake and Polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, Polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100mg tablet) and sodium starch glycolate."
},
{
"NDCCode": "16590-457-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (16590-457-30)",
"NDC11Code": "16590-0457-30",
"ProductNDC": "16590-457",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077397",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Major Depressive Disorder– Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Premenstrual Dysphoric Disorder (PMDD) – Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-IIIR/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol and sparingly soluble in ethanol. Sertraline hydrochloride is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, Polysorbate 80, D&C Yellow # 10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue # 2/Indigo Carmine Aluminum Lake and Polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, Polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100mg tablet) and sodium starch glycolate."
},
{
"NDCCode": "16590-457-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (16590-457-60)",
"NDC11Code": "16590-0457-60",
"ProductNDC": "16590-457",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077397",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
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"IndicationAndUsage": "Major Depressive Disorder– Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Premenstrual Dysphoric Disorder (PMDD) – Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-IIIR/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol and sparingly soluble in ethanol. Sertraline hydrochloride is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, Polysorbate 80, D&C Yellow # 10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue # 2/Indigo Carmine Aluminum Lake and Polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, Polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100mg tablet) and sodium starch glycolate."
},
{
"NDCCode": "16590-457-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (16590-457-90)",
"NDC11Code": "16590-0457-90",
"ProductNDC": "16590-457",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077397",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
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"ProductNdcExcludeFlag": "E",
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"IndicationAndUsage": "Major Depressive Disorder– Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Premenstrual Dysphoric Disorder (PMDD) – Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-IIIR/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol and sparingly soluble in ethanol. Sertraline hydrochloride is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, Polysorbate 80, D&C Yellow # 10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue # 2/Indigo Carmine Aluminum Lake and Polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, Polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100mg tablet) and sodium starch glycolate."
},
{
"NDCCode": "16714-457-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (16714-457-01) ",
"NDC11Code": "16714-0457-01",
"ProductNDC": "16714-457",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine",
"NonProprietaryName": "Quetiapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151201",
"EndMarketingDate": "20250331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202152",
"LabelerName": "Northstar RxLLC",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20151201",
"EndMarketingDatePackage": "20250331",
"SamplePackage": "N",
"Description": "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 C 42H 50N 6O 4S 2C 4H 4O 4 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. Quetiapine tablet, USP is supplied for oral administration as 25 mg (round, pink), 50 mg (round, white to off white), 100 mg (round, yellow), 200 mg (round, white to off white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, 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 quetiapine fumarate, USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains quetiapine fumarate, USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains quetiapine fumarate, USP equivalent to 100 mg quetiapine. Each 200 mg tablet contains quetiapine fumarate, USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains quetiapine fumarate, USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains quetiapine fumarate, USP equivalent to 400 mg quetiapine."
}
]
}
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<SubstanceName>VERBASCUM THAPSUS</SubstanceName>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
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<PackageDescription>100 PELLET in 1 VIAL, SINGLE-DOSE (15631-0457-0) </PackageDescription>
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<SubstanceName>VERBASCUM THAPSUS</SubstanceName>
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<LastUpdate>2022-01-04</LastUpdate>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<SubstanceName>VERBASCUM THAPSUS</SubstanceName>
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<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
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<PackageDescription>750 PELLET in 1 PACKAGE (15631-0457-3) </PackageDescription>
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<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>VERBASCUM THAPSUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
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<NDCCode>15631-0457-5</NDCCode>
<PackageDescription>12500 PELLET in 1 PACKAGE (15631-0457-5) </PackageDescription>
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<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>VERBASCUM THAPSUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
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<NDCCode>12658-0457-1</NDCCode>
<PackageDescription>4 kg in 1 DRUM (12658-0457-1) </PackageDescription>
<NDC11Code>12658-0457-01</NDC11Code>
<ProductNDC>12658-0457</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Acetazolamide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
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<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>ZAKLADY FARMACEUTYCZNE POLPHARMA S A</LabelerName>
<SubstanceName>ACETAZOLAMIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>kg/4kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JAN-82</StartMarketingDatePackage>
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<NDCCode>17856-0457-3</NDCCode>
<PackageDescription>72 POUCH in 1 CASE (17856-0457-3) > 4 g in 1 POUCH</PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Polyethylene Glycol 3350</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060906</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077706</ApplicationNumber>
<LabelerName>Atlantic Biologicals Corps</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350</SubstanceName>
<StrengthNumber>17</StrengthNumber>
<StrengthUnit>g/17g</StrengthUnit>
<Pharm_Classes>Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of occasional constipation. This product should be used for 2 weeks or less or as directed by a physician.</IndicationAndUsage>
<Description>A white powder for reconstitution. Polyethylene Glycol 3350 NF (Polyethylene Glycol 3350 Powder For Oral Solution) is a synthetic polyglycol having an average molecular weight of 3350. The actual molecular weight is not less than 90.0 percent and not greater than 110.0 percent of the nominal value. The chemical formula is HO(C2H4O)nH in which n represents the average number of oxyethylene groups. Below 55°C it is a free flowing white powder freely soluble in water. Polyethylene Glycol 3350 NF is an osmotic agent for the treatment of constipation.</Description>
</NDC>
<NDC>
<NDCCode>17856-0457-4</NDCCode>
<PackageDescription>72 POUCH in 1 CASE (17856-0457-4) > 4.25 g in 1 POUCH</PackageDescription>
<NDC11Code>17856-0457-04</NDC11Code>
<ProductNDC>17856-0457</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Polyethylene Glycol 3350</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060906</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077706</ApplicationNumber>
<LabelerName>Atlantic Biologicals Corps</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350</SubstanceName>
<StrengthNumber>17</StrengthNumber>
<StrengthUnit>g/17g</StrengthUnit>
<Pharm_Classes>Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of occasional constipation. This product should be used for 2 weeks or less or as directed by a physician.</IndicationAndUsage>
<Description>A white powder for reconstitution. Polyethylene Glycol 3350 NF (Polyethylene Glycol 3350 Powder For Oral Solution) is a synthetic polyglycol having an average molecular weight of 3350. The actual molecular weight is not less than 90.0 percent and not greater than 110.0 percent of the nominal value. The chemical formula is HO(C2H4O)nH in which n represents the average number of oxyethylene groups. Below 55°C it is a free flowing white powder freely soluble in water. Polyethylene Glycol 3350 NF is an osmotic agent for the treatment of constipation.</Description>
</NDC>
<NDC>
<NDCCode>49288-0457-4</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49288-0457-4)</PackageDescription>
<NDC11Code>49288-0457-04</NDC11Code>
<ProductNDC>49288-0457</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sage Mixture</ProprietaryName>
<NonProprietaryName>Sage Mixture</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>ARTEMISIA VULGARIS POLLEN; ARTEMISIA ABSINTHIUM POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA LUDOVICIANA POLLEN</SubstanceName>
<StrengthNumber>.0125; .0125; .0125; .0125</StrengthNumber>
<StrengthUnit>g/mL; g/mL; g/mL; g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>50090-0457-4</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (50090-0457-4) </PackageDescription>
<NDC11Code>50090-0457-04</NDC11Code>
<ProductNDC>50090-0457</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Piroxicam</ProprietaryName>
<NonProprietaryName>Piroxicam</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074118</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>PIROXICAM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160629</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51552-0457-4</NDCCode>
<PackageDescription>25 g in 1 CONTAINER (51552-0457-4) </PackageDescription>
<NDC11Code>51552-0457-04</NDC11Code>
<ProductNDC>51552-0457</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Pirpxicam</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19980401</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>PIROXICAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-APR-98</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>58443-0457-4</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE (58443-0457-4) </PackageDescription>
<NDC11Code>58443-0457-04</NDC11Code>
<ProductNDC>58443-0457</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Australian Gold</ProprietaryName>
<ProprietaryNameSuffix>Broad Spectrum Spf 4</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Octocrylene</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201222</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Prime Enterprises, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>9.02; 9.02</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71335-0457-4</NDCCode>
<PackageDescription>90 TABLET, COATED in 1 BOTTLE (71335-0457-4) </PackageDescription>
<NDC11Code>71335-0457-04</NDC11Code>
<ProductNDC>71335-0457</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076118</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benazepril hydrochloride tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in Black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with thiazide diuretics.</IndicationAndUsage>
<Description>Benazepril hydrochloride, USP is a white to off-white crystalline powder, soluble (> 100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is benazepril 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C24H28N2O5HCl and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril hydrochloride is supplied as film-coated tablets containing 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are carnauba wax, colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide, and triacetin. The 10 mg tablet also contains FD&C Red No. 40 aluminum lake. The 20 mg tablet also contains black iron oxide and yellow iron oxide. The 40 mg tablet also contains FD&C Blue No. 2 aluminum lake. Benazepril hydrochloride tablets USP, 5 mg, 10 mg, 20 mg and 40 mg meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>0078-0457-05</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0078-0457-05) </PackageDescription>
<NDC11Code>00078-0457-05</NDC11Code>
<ProductNDC>0078-0457</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trileptal</ProprietaryName>
<NonProprietaryName>Oxcarbazepine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000130</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021014</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>OXCARBAZEPINE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRILEPTAL is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.</IndicationAndUsage>
<Description>TRILEPTAL is an AED available as 150 mg, 300 mg, and 600 mg film-coated tablets for oral administration. TRILEPTAL is also available as a 300 mg/5 mL (60 mg/mL) oral suspension. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is a white to faintly orange crystalline powder. It is slightly soluble in chloroform, dichloromethane, acetone, and methanol and practically insoluble in ethanol, ether and water. Its molecular weight is 252.27 g/mol. TRILEPTAL film-coated tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide. TRILEPTAL oral suspension contains the following inactive ingredients: ascorbic acid; dispersible cellulose; ethanol; macrogol stearate; methyl parahydroxybenzoate; propylene glycol; propyl parahydroxybenzoate; purified water; sodium saccharin; sorbic acid; sorbitol; yellow-plum-lemon aroma.</Description>
</NDC>
<NDC>
<NDCCode>0078-0457-35</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0457-35) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0078-0457-61) </PackageDescription>
<NDC11Code>00078-0457-35</NDC11Code>
<ProductNDC>0078-0457</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trileptal</ProprietaryName>
<NonProprietaryName>Oxcarbazepine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000130</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021014</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>OXCARBAZEPINE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRILEPTAL is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.</IndicationAndUsage>
<Description>TRILEPTAL is an AED available as 150 mg, 300 mg, and 600 mg film-coated tablets for oral administration. TRILEPTAL is also available as a 300 mg/5 mL (60 mg/mL) oral suspension. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is a white to faintly orange crystalline powder. It is slightly soluble in chloroform, dichloromethane, acetone, and methanol and practically insoluble in ethanol, ether and water. Its molecular weight is 252.27 g/mol. TRILEPTAL film-coated tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide. TRILEPTAL oral suspension contains the following inactive ingredients: ascorbic acid; dispersible cellulose; ethanol; macrogol stearate; methyl parahydroxybenzoate; propylene glycol; propyl parahydroxybenzoate; purified water; sodium saccharin; sorbic acid; sorbitol; yellow-plum-lemon aroma.</Description>
</NDC>
<NDC>
<NDCCode>0168-0457-04</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0168-0457-04) > 120 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0457-04</NDC11Code>
<ProductNDC>0168-0457</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140714</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200735</ApplicationNumber>
<LabelerName>Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinonide cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older (1). Limitation of Use: : 1 Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis (1). , 2 Avoid use on the face, groin, or axillae (1.2). , 3 Avoid use in perioral dermatitis or rosacea. .</IndicationAndUsage>
<Description>Fluocinonide cream USP, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.58. It has the following chemical structure:. Fluocinonide is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol. Each gram of fluocinonide cream USP, 0.1% contains 1 mg fluocinonide in a cream base of propylene glycol USP, diethylene glycol monoethyl ether NF, glyceryl stearate (and) PEG-100 stearate, purified water USP, glyceryl monostearate NF, white petrolatum USP, carbomer 980 NF, diisopropanolamine, and citric acid USP.</Description>
</NDC>
<NDC>
<NDCCode>0168-0457-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0168-0457-30) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0457-30</NDC11Code>
<ProductNDC>0168-0457</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140714</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200735</ApplicationNumber>
<LabelerName>Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinonide cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older (1). Limitation of Use: : 1 Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis (1). , 2 Avoid use on the face, groin, or axillae (1.2). , 3 Avoid use in perioral dermatitis or rosacea. .</IndicationAndUsage>
<Description>Fluocinonide cream USP, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.58. It has the following chemical structure:. Fluocinonide is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol. Each gram of fluocinonide cream USP, 0.1% contains 1 mg fluocinonide in a cream base of propylene glycol USP, diethylene glycol monoethyl ether NF, glyceryl stearate (and) PEG-100 stearate, purified water USP, glyceryl monostearate NF, white petrolatum USP, carbomer 980 NF, diisopropanolamine, and citric acid USP.</Description>
</NDC>
<NDC>
<NDCCode>0168-0457-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0168-0457-60) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0457-60</NDC11Code>
<ProductNDC>0168-0457</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140714</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200735</ApplicationNumber>
<LabelerName>Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinonide cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older (1). Limitation of Use: : 1 Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis (1). , 2 Avoid use on the face, groin, or axillae (1.2). , 3 Avoid use in perioral dermatitis or rosacea. .</IndicationAndUsage>
<Description>Fluocinonide cream USP, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.58. It has the following chemical structure:. Fluocinonide is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol. Each gram of fluocinonide cream USP, 0.1% contains 1 mg fluocinonide in a cream base of propylene glycol USP, diethylene glycol monoethyl ether NF, glyceryl stearate (and) PEG-100 stearate, purified water USP, glyceryl monostearate NF, white petrolatum USP, carbomer 980 NF, diisopropanolamine, and citric acid USP.</Description>
</NDC>
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<PackageDescription>1 APPLICATOR in 1 BLISTER PACK (10812-457-01) > 4.9 g in 1 APPLICATOR</PackageDescription>
<NDC11Code>10812-0457-01</NDC11Code>
<ProductNDC>10812-457</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Healthy Skin Brightening Eye Perfector</ProprietaryName>
<ProprietaryNameSuffix>Sunscreen Broad Spectrum Spf25 - Light 10</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130524</StartMarketingDate>
<EndMarketingDate>20181201</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>18.8</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-12-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>11410-457-10</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (11410-457-10) / 177.4 mL in 1 TUBE</PackageDescription>
<NDC11Code>11410-0457-10</NDC11Code>
<ProductNDC>11410-457</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Proactiv Clean Mineral Acne Cleanser</ProprietaryName>
<NonProprietaryName>Sulfur</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220815</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>Alchemee, LLC</LabelerName>
<SubstanceName>SULFUR</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the management of acne.</IndicationAndUsage>
</NDC>
<NDC>
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<PackageDescription>1 BOTTLE in 1 CARTON (11822-0457-0) > 25 CAPSULE, LIQUID FILLED in 1 BOTTLE</PackageDescription>
<NDC11Code>11822-0457-00</NDC11Code>
<ProductNDC>11822-0457</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Relief</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207235</ApplicationNumber>
<LabelerName>Rite Aid Corporation</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11822-0457-1</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (11822-0457-1) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE</PackageDescription>
<NDC11Code>11822-0457-01</NDC11Code>
<ProductNDC>11822-0457</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Relief</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207235</ApplicationNumber>
<LabelerName>Rite Aid Corporation</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14141-457-01</NDCCode>
<PackageDescription>4 g in 1 CARTON (14141-457-01) </PackageDescription>
<NDC11Code>14141-0457-01</NDC11Code>
<ProductNDC>14141-457</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ultra Balm Moisturizing Protective Balm For Lips Spf 20 Nude Caramel</ProprietaryName>
<NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210616</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>BEL STAR S A</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>7.5; 4.9</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Stop use and ask a doctor ifrash occurs.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16590-457-15</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE (16590-457-15)</PackageDescription>
<NDC11Code>16590-0457-15</NDC11Code>
<ProductNDC>16590-457</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077397</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Major Depressive Disorder– Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Premenstrual Dysphoric Disorder (PMDD) – Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-IIIR/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol and sparingly soluble in ethanol. Sertraline hydrochloride is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, Polysorbate 80, D&C Yellow # 10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue # 2/Indigo Carmine Aluminum Lake and Polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, Polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100mg tablet) and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>16590-457-28</NDCCode>
<PackageDescription>28 TABLET in 1 BOTTLE (16590-457-28)</PackageDescription>
<NDC11Code>16590-0457-28</NDC11Code>
<ProductNDC>16590-457</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077397</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Major Depressive Disorder– Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Premenstrual Dysphoric Disorder (PMDD) – Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-IIIR/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol and sparingly soluble in ethanol. Sertraline hydrochloride is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, Polysorbate 80, D&C Yellow # 10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue # 2/Indigo Carmine Aluminum Lake and Polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, Polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100mg tablet) and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>16590-457-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (16590-457-30)</PackageDescription>
<NDC11Code>16590-0457-30</NDC11Code>
<ProductNDC>16590-457</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077397</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Major Depressive Disorder– Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Premenstrual Dysphoric Disorder (PMDD) – Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-IIIR/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol and sparingly soluble in ethanol. Sertraline hydrochloride is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, Polysorbate 80, D&C Yellow # 10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue # 2/Indigo Carmine Aluminum Lake and Polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, Polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100mg tablet) and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>16590-457-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (16590-457-60)</PackageDescription>
<NDC11Code>16590-0457-60</NDC11Code>
<ProductNDC>16590-457</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077397</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Major Depressive Disorder– Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Premenstrual Dysphoric Disorder (PMDD) – Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-IIIR/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol and sparingly soluble in ethanol. Sertraline hydrochloride is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, Polysorbate 80, D&C Yellow # 10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue # 2/Indigo Carmine Aluminum Lake and Polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, Polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100mg tablet) and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>16590-457-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (16590-457-90)</PackageDescription>
<NDC11Code>16590-0457-90</NDC11Code>
<ProductNDC>16590-457</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077397</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Major Depressive Disorder– Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Premenstrual Dysphoric Disorder (PMDD) – Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-IIIR/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol and sparingly soluble in ethanol. Sertraline hydrochloride is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, Polysorbate 80, D&C Yellow # 10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue # 2/Indigo Carmine Aluminum Lake and Polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, Polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100mg tablet) and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>16714-457-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (16714-457-01) </PackageDescription>
<NDC11Code>16714-0457-01</NDC11Code>
<ProductNDC>16714-457</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine</ProprietaryName>
<NonProprietaryName>Quetiapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151201</StartMarketingDate>
<EndMarketingDate>20250331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202152</ApplicationNumber>
<LabelerName>Northstar RxLLC</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20151201</StartMarketingDatePackage>
<EndMarketingDatePackage>20250331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>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 C 42H 50N 6O 4S 2C 4H 4O 4 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. Quetiapine tablet, USP is supplied for oral administration as 25 mg (round, pink), 50 mg (round, white to off white), 100 mg (round, yellow), 200 mg (round, white to off white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, 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 quetiapine fumarate, USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains quetiapine fumarate, USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains quetiapine fumarate, USP equivalent to 100 mg quetiapine. Each 200 mg tablet contains quetiapine fumarate, USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains quetiapine fumarate, USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains quetiapine fumarate, USP equivalent to 400 mg quetiapine.</Description>
</NDC>
</NDCList>