{
"NDC": [
{
"NDCCode": "12719-0068-8",
"PackageDescription": "10000 TABLET in 1 BOTTLE, PLASTIC (12719-0068-8)",
"NDC11Code": "12719-0068-08",
"ProductNDC": "12719-0068",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"StartMarketingDate": "19750602",
"EndMarketingDate": "20200701",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Productos Roche S.A. de C.V.",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "12719-0068-9",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (12719-0068-9)",
"NDC11Code": "12719-0068-09",
"ProductNDC": "12719-0068",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"StartMarketingDate": "19750602",
"EndMarketingDate": "20200701",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Productos Roche S.A. de C.V.",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "12719-0058-8",
"PackageDescription": "10000 TABLET in 1 BOTTLE, PLASTIC (12719-0058-8)",
"NDC11Code": "12719-0058-08",
"ProductNDC": "12719-0058",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"StartMarketingDate": "19750602",
"EndMarketingDate": "20190801",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Productos Roche S.A. de C.V.",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "58118-0068-8",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (58118-0068-8)",
"NDC11Code": "58118-0068-08",
"ProductNDC": "58118-0068",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078332",
"LabelerName": "Clinical Solutions Wholesale, LLC",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-11-08"
},
{
"NDCCode": "0009-0068-07",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0009-0068-07) ",
"NDC11Code": "00009-0068-07",
"ProductNDC": "0009-0068",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xanax",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20030117",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021434",
"LabelerName": "PHARMACIA & UPJOHN COMPANY LLC",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20030117",
"EndMarketingDatePackage": "20250131",
"SamplePackage": "N",
"IndicationAndUsage": "XANAX XR is indicated for the treatment of panic disorder with or without agoraphobia, in adults.",
"Description": "XANAX XR contains alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The molecular formula is C17H13ClN4 which corresponds to a molecular weight of 308.76. The structural formula is represented below. Alprazolam is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each XANAX XR extended-release tablet, for oral administration, contains 0.5 mg, 1 mg, 2 mg, or 3 mg of alprazolam. The inactive ingredients are colloidal silicon dioxide, hypromellose, lactose, and magnesium stearate. In addition, the 1 mg and 3 mg tablets contain D & C yellow No. 10 and the 2 mg and 3 mg tablets contain FD&C blue No. 2."
},
{
"NDCCode": "0068-0597-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (0068-0597-01) / 10 mL in 1 VIAL, GLASS",
"NDC11Code": "00068-0597-01",
"ProductNDC": "0068-0597",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rifadin Iv",
"NonProprietaryName": "Rifampin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19890525",
"EndMarketingDate": "20260930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050627",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "RIFAMPIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19890525",
"EndMarketingDatePackage": "20260930",
"SamplePackage": "N",
"IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.",
"Description": "RIFADIN (rifampin capsules USP) for oral administration contains 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain, as inactive ingredients: corn starch, D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide. RIFADIN IV (rifampin for injection USP) contains rifampin 600 mg, sodium formaldehyde sulfoxylate 10 mg, and sodium hydroxide to adjust pH. Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either. 3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22–heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca [1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is."
},
{
"NDCCode": "0068-0599-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (0068-0599-01) / 10 mL in 1 VIAL, GLASS",
"NDC11Code": "00068-0599-01",
"ProductNDC": "0068-0599",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rifadin Iv Novaplus",
"NonProprietaryName": "Rifampin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170201",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050627",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "RIFAMPIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170201",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.",
"Description": "RIFADIN (rifampin capsules USP) for oral administration contains 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain, as inactive ingredients: corn starch, D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide. RIFADIN IV (rifampin for injection USP) contains rifampin 600 mg, sodium formaldehyde sulfoxylate 10 mg, and sodium hydroxide to adjust pH. Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either. 3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-Hexahydroxy-23-methoxy-2,4,12,16,18,20,22–heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is."
},
{
"NDCCode": "0280-0068-01",
"PackageDescription": "10 POUCH in 1 CARTON (0280-0068-01) / 2 TABLET, EFFERVESCENT in 1 POUCH",
"NDC11Code": "00280-0068-01",
"ProductNDC": "0280-0068",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alka-seltzer Plus Severe Cold Night Powerfast Fizz",
"NonProprietaryName": "Aspirin, Doxylamine Succinate, Dextromethorphan Hydrobromide, Phenylephrine Bitartrate",
"DosageFormName": "TABLET, EFFERVESCENT",
"RouteName": "ORAL",
"StartMarketingDate": "20210712",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "ASPIRIN; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE BITARTRATE",
"StrengthNumber": "325; 6.25; 10; 7.8",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Antihistamine [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine Receptor Antagonists [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210712",
"SamplePackage": "N",
"IndicationAndUsage": "Uses : 1 temporarily relieves these symptoms due to a cold: minor aches and pains headache runny nose sinus congestion and pressurecoughsneezingsore throatnasal congestion, 2 temporarily reduces fever."
},
{
"NDCCode": "16590-068-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (16590-068-05) > 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "16590-0068-05",
"ProductNDC": "16590-068",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexamethasone Sodium Phosphate",
"NonProprietaryName": "Dexamethasone Sodium Phosphate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19960726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040069",
"LabelerName": "Stat Rx USA",
"SubstanceName": "DEXAMETHASONE SODIUM PHOSPHATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the treatment of the following conditions. Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical or thermal burns, or penetration of foreign bodies. Steroid responsive inflammatory conditions of the external auditory meatus, such as allergic otitis externa, selected purulent and nonpurulent infective otitis externa when the hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.",
"Description": "Dexamethasone Sodium Phosphate Ophthalmic Solution USP, is a sterile, topical steroid solution. The active ingredient is represented by the following structural formula. C22H28FNa2O8P. Mol. wt. 516.41. Chemical Name: 9-fluoro-11β, 17-dihydroxy-16α-methyl-21-[phosphonooxy]pregna-1, 4-diene-3,20-dione disodium salt. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic. Dexamethasone is a synthetic analog of naturally occurring glucocorticoids (hydrocortisone and cortisone). Dexamethasone sodium phosphate is a water soluble, inorganic ester of dexamethasone. It is approximately three thousand times more soluble at 25°C than hydrocortisone. Each mL Contains: ACTIVE: Dexamethasone Sodium Phosphate, [equivalent to 1 mg (0.1%) Dexamethasone Phosphate]. INACTIVES: Sodium Citrate, Sodium Borate, Creatinine, Polysorbate 80, Edetate Disodium Dihydrate, Purified Water. Hydrochloric Acid may be added to adjust pH (6.6 - 7.8). PRESERVATIVES ADDED: Sodium Bisulfite 0.1%, Phenylethyl Alcohol 0.25%, Benzalkonium Chloride 0.02%."
},
{
"NDCCode": "17089-068-20",
"PackageDescription": "2 TUBE in 1 BOX (17089-068-20) / 4 g in 1 TUBE",
"NDC11Code": "17089-0068-20",
"ProductNDC": "17089-068",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti Age Vein",
"NonProprietaryName": "Aconitum Napellus - Apis Mellifera - Arnica Montana - Arsenic Trioxide - Atropa Belladonna - Calcium Fluoride - Centella Asiatica - Cinchona Officinalis Bark - Cranberry - Horse Chestnut - Iron - Lachesis Muta Venom - Mercury - Pineapple - Pulsatilla Vulgaris - Sus Scrofa Artery - Sus Scrofa Small Intestine Mucosa Lymph Follicle - Sus Scrofa Vein - Viscum Album Fruit - Witch Hazel -",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "ACONITUM NAPELLUS; HORSE CHESTNUT; PINEAPPLE; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; SUS SCROFA ARTERY; ATROPA BELLADONNA; CALCIUM FLUORIDE; CINCHONA OFFICINALIS BARK; IRON; WITCH HAZEL; CENTELLA ASIATICA; LACHESIS MUTA VENOM; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; MERCURY; CRANBERRY; PULSATILLA VULGARIS; SUS SCROFA VEIN; VISCUM ALBUM FRUIT",
"StrengthNumber": "10; 3; 3; 10; 10; 12; 4; 10; 8; 10; 10; 3; 3; 10; 7; 10; 3; 10; 4; 3",
"StrengthUnit": "[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Fruit Proteins [EXT], Fruit Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181221",
"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve. Take 15 minutes before meals. ."
},
{
"NDCCode": "21130-068-01",
"PackageDescription": "24 PACKET in 1 BOX (21130-068-01) / 1 PATCH in 1 PACKET / 4.8 mL in 1 PATCH",
"NDC11Code": "21130-0068-01",
"ProductNDC": "21130-068",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Signature Select Instant Hand Sanitizer Wipes With Aloe Vera",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260104",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M005",
"LabelerName": "Living Better Brands LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260104",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. : 1 For hand washing to decrease bacteria on the skin, 2 Recommended for repeated use, 3 Dries in seconds."
},
{
"NDCCode": "21130-068-02",
"PackageDescription": "80 PACKET in 1 PACKAGE (21130-068-02) / 1 PATCH in 1 PACKET / 4.8 mL in 1 PATCH",
"NDC11Code": "21130-0068-02",
"ProductNDC": "21130-068",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Signature Select Instant Hand Sanitizer Wipes With Aloe Vera",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260104",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M005",
"LabelerName": "Living Better Brands LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260104",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. : 1 For hand washing to decrease bacteria on the skin, 2 Recommended for repeated use, 3 Dries in seconds."
},
{
"NDCCode": "21922-068-43",
"PackageDescription": "1 KIT in 1 CARTON (21922-068-43) * 20 g in 1 JAR (21922-067-62) * 40 g in 1 JAR (21922-067-41) * 28 g in 1 BOTTLE, PUMP (21922-067-39) * 40 g in 1 BOTTLE, PUMP (21922-067-42) * 10 g in 1 BOTTLE (21922-066-12) * 7 g in 1 BOTTLE (21922-066-37) * 5 g in 1 BOTTLE (21922-066-36) ",
"NDC11Code": "21922-0068-43",
"ProductNDC": "21922-068",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin And Benzoyl Peroxide",
"NonProprietaryName": "Clindamycin And Benzoyl Peroxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20251007",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204087",
"LabelerName": "Encube Ethicals, Inc.",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251007",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.",
"Description": "Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C18H34ClN2O8PS). The structural formula for clindamycin is represented below. Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7, 8-trideoxy-6-(1-methyl-trans- 4-propyl-L-2-pyrrolidinecarboxamido) -1-thio-L- threo-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide gel, 1%/5%also contains benzoyl peroxide, for topical use.Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula. Benzoyl peroxide has a molecular weight of 242.23. Each gram of clindamycin and benzoyl peroxide gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbopol 980, d-limonene, docusate sodium solution, phosphoric acid, propylene glycol, purified water and sodium hydroxide."
},
{
"NDCCode": "21922-068-44",
"PackageDescription": "1 KIT in 1 CARTON (21922-068-44) * 20 g in 1 JAR (21922-067-62) * 40 g in 1 JAR (21922-067-41) * 28 g in 1 BOTTLE, PUMP (21922-067-39) * 40 g in 1 BOTTLE, PUMP (21922-067-42) * 10 g in 1 BOTTLE (21922-066-12) * 7 g in 1 BOTTLE (21922-066-37) * 5 g in 1 BOTTLE (21922-066-36) ",
"NDC11Code": "21922-0068-44",
"ProductNDC": "21922-068",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin And Benzoyl Peroxide",
"NonProprietaryName": "Clindamycin And Benzoyl Peroxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20251007",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204087",
"LabelerName": "Encube Ethicals, Inc.",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251007",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.",
"Description": "Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C18H34ClN2O8PS). The structural formula for clindamycin is represented below. Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7, 8-trideoxy-6-(1-methyl-trans- 4-propyl-L-2-pyrrolidinecarboxamido) -1-thio-L- threo-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide gel, 1%/5%also contains benzoyl peroxide, for topical use.Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula. Benzoyl peroxide has a molecular weight of 242.23. Each gram of clindamycin and benzoyl peroxide gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbopol 980, d-limonene, docusate sodium solution, phosphoric acid, propylene glycol, purified water and sodium hydroxide."
},
{
"NDCCode": "21922-068-45",
"PackageDescription": "1 KIT in 1 CARTON (21922-068-45) * 20 g in 1 JAR (21922-067-62) * 40 g in 1 JAR (21922-067-41) * 28 g in 1 BOTTLE, PUMP (21922-067-39) * 40 g in 1 BOTTLE, PUMP (21922-067-42) * 10 g in 1 BOTTLE (21922-066-12) * 7 g in 1 BOTTLE (21922-066-37) * 5 g in 1 BOTTLE (21922-066-36) ",
"NDC11Code": "21922-0068-45",
"ProductNDC": "21922-068",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin And Benzoyl Peroxide",
"NonProprietaryName": "Clindamycin And Benzoyl Peroxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20251007",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204087",
"LabelerName": "Encube Ethicals, Inc.",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251007",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.",
"Description": "Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C18H34ClN2O8PS). The structural formula for clindamycin is represented below. Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7, 8-trideoxy-6-(1-methyl-trans- 4-propyl-L-2-pyrrolidinecarboxamido) -1-thio-L- threo-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide gel, 1%/5%also contains benzoyl peroxide, for topical use.Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula. Benzoyl peroxide has a molecular weight of 242.23. Each gram of clindamycin and benzoyl peroxide gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbopol 980, d-limonene, docusate sodium solution, phosphoric acid, propylene glycol, purified water and sodium hydroxide."
},
{
"NDCCode": "21922-068-46",
"PackageDescription": "1 KIT in 1 CARTON (21922-068-46) * 20 g in 1 JAR (21922-067-62) * 40 g in 1 JAR (21922-067-41) * 28 g in 1 BOTTLE, PUMP (21922-067-39) * 40 g in 1 BOTTLE, PUMP (21922-067-42) * 10 g in 1 BOTTLE (21922-066-12) * 7 g in 1 BOTTLE (21922-066-37) * 5 g in 1 BOTTLE (21922-066-36) ",
"NDC11Code": "21922-0068-46",
"ProductNDC": "21922-068",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin And Benzoyl Peroxide",
"NonProprietaryName": "Clindamycin And Benzoyl Peroxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20251007",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204087",
"LabelerName": "Encube Ethicals, Inc.",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251007",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.",
"Description": "Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C18H34ClN2O8PS). The structural formula for clindamycin is represented below. Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7, 8-trideoxy-6-(1-methyl-trans- 4-propyl-L-2-pyrrolidinecarboxamido) -1-thio-L- threo-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide gel, 1%/5%also contains benzoyl peroxide, for topical use.Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula. Benzoyl peroxide has a molecular weight of 242.23. Each gram of clindamycin and benzoyl peroxide gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbopol 980, d-limonene, docusate sodium solution, phosphoric acid, propylene glycol, purified water and sodium hydroxide."
},
{
"NDCCode": "31722-068-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-068-01) ",
"NDC11Code": "31722-0068-01",
"ProductNDC": "31722-068",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216800",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230531",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)]. The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)].",
"Description": "Bupropion hydrochloride, USP is an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.20. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride is white powder, and soluble in water, 0.1 N Hydrochloric acid and in alcohol. The structural formula is:. Bupropion hydrochloride extended-release tablets USP (SR) are supplied for oral administration as 100 mg (red), 150 mg (green), and 200 mg (yellow), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride USP and the inactive ingredients: colloidal silicon dioxide, diluted hydrochloride acid, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium stearyl fumarate, titanium dioxide and is printed with edible black ink. In addition, the 100 mg tablet contains FD&C Red #40, the 150 mg tablet contains FD&C Blue #1 and D&C Yellow #10 Lake and the 200 mg tablet contains D&C Yellow #10 Lake. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "31722-068-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-068-05) ",
"NDC11Code": "31722-0068-05",
"ProductNDC": "31722-068",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216800",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230531",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)]. The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)].",
"Description": "Bupropion hydrochloride, USP is an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.20. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride is white powder, and soluble in water, 0.1 N Hydrochloric acid and in alcohol. The structural formula is:. Bupropion hydrochloride extended-release tablets USP (SR) are supplied for oral administration as 100 mg (red), 150 mg (green), and 200 mg (yellow), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride USP and the inactive ingredients: colloidal silicon dioxide, diluted hydrochloride acid, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium stearyl fumarate, titanium dioxide and is printed with edible black ink. In addition, the 100 mg tablet contains FD&C Red #40, the 150 mg tablet contains FD&C Blue #1 and D&C Yellow #10 Lake and the 200 mg tablet contains D&C Yellow #10 Lake. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "31722-068-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-068-60) ",
"NDC11Code": "31722-0068-60",
"ProductNDC": "31722-068",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216800",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230531",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)]. The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)].",
"Description": "Bupropion hydrochloride, USP is an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.20. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride is white powder, and soluble in water, 0.1 N Hydrochloric acid and in alcohol. The structural formula is:. Bupropion hydrochloride extended-release tablets USP (SR) are supplied for oral administration as 100 mg (red), 150 mg (green), and 200 mg (yellow), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride USP and the inactive ingredients: colloidal silicon dioxide, diluted hydrochloride acid, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium stearyl fumarate, titanium dioxide and is printed with edible black ink. In addition, the 100 mg tablet contains FD&C Red #40, the 150 mg tablet contains FD&C Blue #1 and D&C Yellow #10 Lake and the 200 mg tablet contains D&C Yellow #10 Lake. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "31722-068-90",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-068-90) ",
"NDC11Code": "31722-0068-90",
"ProductNDC": "31722-068",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216800",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230531",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)]. The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)].",
"Description": "Bupropion hydrochloride, USP is an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.20. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride is white powder, and soluble in water, 0.1 N Hydrochloric acid and in alcohol. The structural formula is:. Bupropion hydrochloride extended-release tablets USP (SR) are supplied for oral administration as 100 mg (red), 150 mg (green), and 200 mg (yellow), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride USP and the inactive ingredients: colloidal silicon dioxide, diluted hydrochloride acid, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium stearyl fumarate, titanium dioxide and is printed with edible black ink. In addition, the 100 mg tablet contains FD&C Red #40, the 150 mg tablet contains FD&C Blue #1 and D&C Yellow #10 Lake and the 200 mg tablet contains D&C Yellow #10 Lake. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "33342-068-07",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (33342-068-07) ",
"NDC11Code": "33342-0068-07",
"ProductNDC": "33342-068",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202862",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140822",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated:. As oral formulation for the:. · Treatment of schizophrenia. (1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2). · Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. As Olanzapine and Fluoxetine in Combination for the: Treatment of depressive episodes associated with bipolar I disorder. (1.5) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax. Treatment of treatment resistant depression. (1.6) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg)."
},
{
"NDCCode": "33342-068-11",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (33342-068-11) ",
"NDC11Code": "33342-0068-11",
"ProductNDC": "33342-068",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202862",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140822",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated:. As oral formulation for the:. · Treatment of schizophrenia. (1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2). · Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. As Olanzapine and Fluoxetine in Combination for the: Treatment of depressive episodes associated with bipolar I disorder. (1.5) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax. Treatment of treatment resistant depression. (1.6) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg)."
},
{
"NDCCode": "33342-068-12",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-068-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "33342-0068-12",
"ProductNDC": "33342-068",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202862",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140822",
"SamplePackage": "N",
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"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg)."
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"ProductTypeName": "HUMAN OTC DRUG",
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"SubstanceName": "CHLOROXYLENOL",
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"ProductTypeName": "HUMAN OTC DRUG",
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{
"NDCCode": "42291-068-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (42291-068-30) ",
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"ProductNDC": "42291-068",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
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"ApplicationNumber": "ANDA079022",
"LabelerName": "AvKARE",
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"Description": "Atomoxetine HCl is a selective norepinephrine reuptake inhibitor. Atomoxetine HCl, USP is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)- N-methyl-3-phenyl-3-( o-tolyoxy)-propylamine hydrochloride. The chemical structure is:. C 17H 21NOHCl M.W. 291.82. Atomoxetine HCl, USP is a white to practically white powder, which has a solubility of 27.8 mg/mL in water. Atomoxetine Capsules USP are intended for oral administration only. Each capsule contains atomoxetine HCl, USP equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. The capsules also contain black iron oxide, gelatin, potassium hydroxide, pregelatinized corn starch, propylene glycol, shellac, sodium lauryl sulfate, strong ammonia solution, and titanium dioxide. Additionally the 18 mg and 60 mg capsules contain D&C yellow #10; the 25 mg, 40 mg, and 60 mg capsules contain FD&C blue #1; and the 80 mg and 100 mg capsules contain red iron oxide and yellow iron oxide."
},
{
"NDCCode": "43742-0068-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43742-0068-1)",
"NDC11Code": "43742-0068-01",
"ProductNDC": "43742-0068",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lymphoplus",
"NonProprietaryName": "Trifolium Pratense, Lymph (suis), Spleen (suis), Conium Maculatum, Echinacea, Lycopodium Clavatum, Myrrha, Phytolacca Decandra, Selenium Metallicum, Silicea,",
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"RouteName": "ORAL",
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"EndMarketingDate": "20190304",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Deseret Biologicals, Inc.",
"SubstanceName": "TRIFOLIUM PRATENSE FLOWER; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; CONIUM MACULATUM FLOWERING TOP; ECHINACEA, UNSPECIFIED; LYCOPODIUM CLAVATUM SPORE; MYRRH; PHYTOLACCA AMERICANA ROOT; SELENIUM; SILICON DIOXIDE",
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"Status": "Deprecated",
"LastUpdate": "2019-03-05",
"ProductNdcExcludeFlag": "N"
}
]
}
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<NDC>
<NDCCode>12719-0068-8</NDCCode>
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<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
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<Status>Deprecated</Status>
<LastUpdate>2017-11-08</LastUpdate>
</NDC>
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<ProductNDC>0009-0068</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xanax</ProprietaryName>
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<EndMarketingDate>20250131</EndMarketingDate>
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<LastUpdate>2025-02-04</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20030117</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XANAX XR is indicated for the treatment of panic disorder with or without agoraphobia, in adults.</IndicationAndUsage>
<Description>XANAX XR contains alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The molecular formula is C17H13ClN4 which corresponds to a molecular weight of 308.76. The structural formula is represented below. Alprazolam is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each XANAX XR extended-release tablet, for oral administration, contains 0.5 mg, 1 mg, 2 mg, or 3 mg of alprazolam. The inactive ingredients are colloidal silicon dioxide, hypromellose, lactose, and magnesium stearate. In addition, the 1 mg and 3 mg tablets contain D & C yellow No. 10 and the 2 mg and 3 mg tablets contain FD&C blue No. 2.</Description>
</NDC>
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<NDCCode>0068-0597-01</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (0068-0597-01) / 10 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>00068-0597-01</NDC11Code>
<ProductNDC>0068-0597</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rifadin Iv</ProprietaryName>
<NonProprietaryName>Rifampin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19890525</StartMarketingDate>
<EndMarketingDate>20260930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050627</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>RIFAMPIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19890525</StartMarketingDatePackage>
<EndMarketingDatePackage>20260930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
<Description>RIFADIN (rifampin capsules USP) for oral administration contains 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain, as inactive ingredients: corn starch, D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide. RIFADIN IV (rifampin for injection USP) contains rifampin 600 mg, sodium formaldehyde sulfoxylate 10 mg, and sodium hydroxide to adjust pH. Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either. 3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22–heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca [1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rifadin Iv Novaplus</ProprietaryName>
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<StartMarketingDate>20170201</StartMarketingDate>
<EndMarketingDate>20251031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
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<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
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<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170201</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
<Description>RIFADIN (rifampin capsules USP) for oral administration contains 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain, as inactive ingredients: corn starch, D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide. RIFADIN IV (rifampin for injection USP) contains rifampin 600 mg, sodium formaldehyde sulfoxylate 10 mg, and sodium hydroxide to adjust pH. Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either. 3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-Hexahydroxy-23-methoxy-2,4,12,16,18,20,22–heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>0280-0068-01</NDCCode>
<PackageDescription>10 POUCH in 1 CARTON (0280-0068-01) / 2 TABLET, EFFERVESCENT in 1 POUCH</PackageDescription>
<NDC11Code>00280-0068-01</NDC11Code>
<ProductNDC>0280-0068</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer Plus Severe Cold Night Powerfast Fizz</ProprietaryName>
<NonProprietaryName>Aspirin, Doxylamine Succinate, Dextromethorphan Hydrobromide, Phenylephrine Bitartrate</NonProprietaryName>
<DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210712</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>ASPIRIN; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>325; 6.25; 10; 7.8</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Antihistamine [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine Receptor Antagonists [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses : 1 temporarily relieves these symptoms due to a cold: minor aches and pains headache runny nose sinus congestion and pressurecoughsneezingsore throatnasal congestion, 2 temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16590-068-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (16590-068-05) > 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>16590-0068-05</NDC11Code>
<ProductNDC>16590-068</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexamethasone Sodium Phosphate</ProprietaryName>
<NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19960726</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040069</ApplicationNumber>
<LabelerName>Stat Rx USA</LabelerName>
<SubstanceName>DEXAMETHASONE SODIUM PHOSPHATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the treatment of the following conditions. Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical or thermal burns, or penetration of foreign bodies. Steroid responsive inflammatory conditions of the external auditory meatus, such as allergic otitis externa, selected purulent and nonpurulent infective otitis externa when the hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.</IndicationAndUsage>
<Description>Dexamethasone Sodium Phosphate Ophthalmic Solution USP, is a sterile, topical steroid solution. The active ingredient is represented by the following structural formula. C22H28FNa2O8P. Mol. wt. 516.41. Chemical Name: 9-fluoro-11β, 17-dihydroxy-16α-methyl-21-[phosphonooxy]pregna-1, 4-diene-3,20-dione disodium salt. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic. Dexamethasone is a synthetic analog of naturally occurring glucocorticoids (hydrocortisone and cortisone). Dexamethasone sodium phosphate is a water soluble, inorganic ester of dexamethasone. It is approximately three thousand times more soluble at 25°C than hydrocortisone. Each mL Contains: ACTIVE: Dexamethasone Sodium Phosphate, [equivalent to 1 mg (0.1%) Dexamethasone Phosphate]. INACTIVES: Sodium Citrate, Sodium Borate, Creatinine, Polysorbate 80, Edetate Disodium Dihydrate, Purified Water. Hydrochloric Acid may be added to adjust pH (6.6 - 7.8). PRESERVATIVES ADDED: Sodium Bisulfite 0.1%, Phenylethyl Alcohol 0.25%, Benzalkonium Chloride 0.02%.</Description>
</NDC>
<NDC>
<NDCCode>17089-068-20</NDCCode>
<PackageDescription>2 TUBE in 1 BOX (17089-068-20) / 4 g in 1 TUBE</PackageDescription>
<NDC11Code>17089-0068-20</NDC11Code>
<ProductNDC>17089-068</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti Age Vein</ProprietaryName>
<NonProprietaryName>Aconitum Napellus - Apis Mellifera - Arnica Montana - Arsenic Trioxide - Atropa Belladonna - Calcium Fluoride - Centella Asiatica - Cinchona Officinalis Bark - Cranberry - Horse Chestnut - Iron - Lachesis Muta Venom - Mercury - Pineapple - Pulsatilla Vulgaris - Sus Scrofa Artery - Sus Scrofa Small Intestine Mucosa Lymph Follicle - Sus Scrofa Vein - Viscum Album Fruit - Witch Hazel -</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; HORSE CHESTNUT; PINEAPPLE; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; SUS SCROFA ARTERY; ATROPA BELLADONNA; CALCIUM FLUORIDE; CINCHONA OFFICINALIS BARK; IRON; WITCH HAZEL; CENTELLA ASIATICA; LACHESIS MUTA VENOM; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; MERCURY; CRANBERRY; PULSATILLA VULGARIS; SUS SCROFA VEIN; VISCUM ALBUM FRUIT</SubstanceName>
<StrengthNumber>10; 3; 3; 10; 10; 12; 4; 10; 8; 10; 10; 3; 3; 10; 7; 10; 3; 10; 4; 3</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Fruit Proteins [EXT], Fruit Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve. Take 15 minutes before meals. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21130-068-01</NDCCode>
<PackageDescription>24 PACKET in 1 BOX (21130-068-01) / 1 PATCH in 1 PACKET / 4.8 mL in 1 PATCH</PackageDescription>
<NDC11Code>21130-0068-01</NDC11Code>
<ProductNDC>21130-068</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Signature Select Instant Hand Sanitizer Wipes With Aloe Vera</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260104</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M005</ApplicationNumber>
<LabelerName>Living Better Brands LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. : 1 For hand washing to decrease bacteria on the skin, 2 Recommended for repeated use, 3 Dries in seconds.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21130-068-02</NDCCode>
<PackageDescription>80 PACKET in 1 PACKAGE (21130-068-02) / 1 PATCH in 1 PACKET / 4.8 mL in 1 PATCH</PackageDescription>
<NDC11Code>21130-0068-02</NDC11Code>
<ProductNDC>21130-068</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Signature Select Instant Hand Sanitizer Wipes With Aloe Vera</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260104</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M005</ApplicationNumber>
<LabelerName>Living Better Brands LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. : 1 For hand washing to decrease bacteria on the skin, 2 Recommended for repeated use, 3 Dries in seconds.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21922-068-43</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (21922-068-43) * 20 g in 1 JAR (21922-067-62) * 40 g in 1 JAR (21922-067-41) * 28 g in 1 BOTTLE, PUMP (21922-067-39) * 40 g in 1 BOTTLE, PUMP (21922-067-42) * 10 g in 1 BOTTLE (21922-066-12) * 7 g in 1 BOTTLE (21922-066-37) * 5 g in 1 BOTTLE (21922-066-36) </PackageDescription>
<NDC11Code>21922-0068-43</NDC11Code>
<ProductNDC>21922-068</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin And Benzoyl Peroxide</ProprietaryName>
<NonProprietaryName>Clindamycin And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20251007</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204087</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
<Description>Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C18H34ClN2O8PS). The structural formula for clindamycin is represented below. Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7, 8-trideoxy-6-(1-methyl-trans- 4-propyl-L-2-pyrrolidinecarboxamido) -1-thio-L- threo-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide gel, 1%/5%also contains benzoyl peroxide, for topical use.Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula. Benzoyl peroxide has a molecular weight of 242.23. Each gram of clindamycin and benzoyl peroxide gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbopol 980, d-limonene, docusate sodium solution, phosphoric acid, propylene glycol, purified water and sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>21922-068-44</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (21922-068-44) * 20 g in 1 JAR (21922-067-62) * 40 g in 1 JAR (21922-067-41) * 28 g in 1 BOTTLE, PUMP (21922-067-39) * 40 g in 1 BOTTLE, PUMP (21922-067-42) * 10 g in 1 BOTTLE (21922-066-12) * 7 g in 1 BOTTLE (21922-066-37) * 5 g in 1 BOTTLE (21922-066-36) </PackageDescription>
<NDC11Code>21922-0068-44</NDC11Code>
<ProductNDC>21922-068</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin And Benzoyl Peroxide</ProprietaryName>
<NonProprietaryName>Clindamycin And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20251007</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204087</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
<Description>Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C18H34ClN2O8PS). The structural formula for clindamycin is represented below. Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7, 8-trideoxy-6-(1-methyl-trans- 4-propyl-L-2-pyrrolidinecarboxamido) -1-thio-L- threo-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide gel, 1%/5%also contains benzoyl peroxide, for topical use.Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula. Benzoyl peroxide has a molecular weight of 242.23. Each gram of clindamycin and benzoyl peroxide gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbopol 980, d-limonene, docusate sodium solution, phosphoric acid, propylene glycol, purified water and sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>21922-068-45</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (21922-068-45) * 20 g in 1 JAR (21922-067-62) * 40 g in 1 JAR (21922-067-41) * 28 g in 1 BOTTLE, PUMP (21922-067-39) * 40 g in 1 BOTTLE, PUMP (21922-067-42) * 10 g in 1 BOTTLE (21922-066-12) * 7 g in 1 BOTTLE (21922-066-37) * 5 g in 1 BOTTLE (21922-066-36) </PackageDescription>
<NDC11Code>21922-0068-45</NDC11Code>
<ProductNDC>21922-068</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin And Benzoyl Peroxide</ProprietaryName>
<NonProprietaryName>Clindamycin And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20251007</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204087</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
<Description>Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C18H34ClN2O8PS). The structural formula for clindamycin is represented below. Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7, 8-trideoxy-6-(1-methyl-trans- 4-propyl-L-2-pyrrolidinecarboxamido) -1-thio-L- threo-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide gel, 1%/5%also contains benzoyl peroxide, for topical use.Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula. Benzoyl peroxide has a molecular weight of 242.23. Each gram of clindamycin and benzoyl peroxide gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbopol 980, d-limonene, docusate sodium solution, phosphoric acid, propylene glycol, purified water and sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>21922-068-46</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (21922-068-46) * 20 g in 1 JAR (21922-067-62) * 40 g in 1 JAR (21922-067-41) * 28 g in 1 BOTTLE, PUMP (21922-067-39) * 40 g in 1 BOTTLE, PUMP (21922-067-42) * 10 g in 1 BOTTLE (21922-066-12) * 7 g in 1 BOTTLE (21922-066-37) * 5 g in 1 BOTTLE (21922-066-36) </PackageDescription>
<NDC11Code>21922-0068-46</NDC11Code>
<ProductNDC>21922-068</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin And Benzoyl Peroxide</ProprietaryName>
<NonProprietaryName>Clindamycin And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20251007</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204087</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
<Description>Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C18H34ClN2O8PS). The structural formula for clindamycin is represented below. Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7, 8-trideoxy-6-(1-methyl-trans- 4-propyl-L-2-pyrrolidinecarboxamido) -1-thio-L- threo-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide gel, 1%/5%also contains benzoyl peroxide, for topical use.Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula. Benzoyl peroxide has a molecular weight of 242.23. Each gram of clindamycin and benzoyl peroxide gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbopol 980, d-limonene, docusate sodium solution, phosphoric acid, propylene glycol, purified water and sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>31722-068-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-068-01) </PackageDescription>
<NDC11Code>31722-0068-01</NDC11Code>
<ProductNDC>31722-068</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230531</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216800</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)]. The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Bupropion hydrochloride, USP is an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.20. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride is white powder, and soluble in water, 0.1 N Hydrochloric acid and in alcohol. The structural formula is:. Bupropion hydrochloride extended-release tablets USP (SR) are supplied for oral administration as 100 mg (red), 150 mg (green), and 200 mg (yellow), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride USP and the inactive ingredients: colloidal silicon dioxide, diluted hydrochloride acid, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium stearyl fumarate, titanium dioxide and is printed with edible black ink. In addition, the 100 mg tablet contains FD&C Red #40, the 150 mg tablet contains FD&C Blue #1 and D&C Yellow #10 Lake and the 200 mg tablet contains D&C Yellow #10 Lake. FDA approved dissolution test specifications differ from USP.</Description>
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<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)]. The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Bupropion hydrochloride, USP is an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.20. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride is white powder, and soluble in water, 0.1 N Hydrochloric acid and in alcohol. The structural formula is:. Bupropion hydrochloride extended-release tablets USP (SR) are supplied for oral administration as 100 mg (red), 150 mg (green), and 200 mg (yellow), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride USP and the inactive ingredients: colloidal silicon dioxide, diluted hydrochloride acid, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium stearyl fumarate, titanium dioxide and is printed with edible black ink. In addition, the 100 mg tablet contains FD&C Red #40, the 150 mg tablet contains FD&C Blue #1 and D&C Yellow #10 Lake and the 200 mg tablet contains D&C Yellow #10 Lake. FDA approved dissolution test specifications differ from USP.</Description>
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<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)]. The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Bupropion hydrochloride, USP is an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.20. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride is white powder, and soluble in water, 0.1 N Hydrochloric acid and in alcohol. The structural formula is:. Bupropion hydrochloride extended-release tablets USP (SR) are supplied for oral administration as 100 mg (red), 150 mg (green), and 200 mg (yellow), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride USP and the inactive ingredients: colloidal silicon dioxide, diluted hydrochloride acid, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium stearyl fumarate, titanium dioxide and is printed with edible black ink. In addition, the 100 mg tablet contains FD&C Red #40, the 150 mg tablet contains FD&C Blue #1 and D&C Yellow #10 Lake and the 200 mg tablet contains D&C Yellow #10 Lake. FDA approved dissolution test specifications differ from USP.</Description>
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<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)]. The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Bupropion hydrochloride, USP is an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.20. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride is white powder, and soluble in water, 0.1 N Hydrochloric acid and in alcohol. The structural formula is:. Bupropion hydrochloride extended-release tablets USP (SR) are supplied for oral administration as 100 mg (red), 150 mg (green), and 200 mg (yellow), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride USP and the inactive ingredients: colloidal silicon dioxide, diluted hydrochloride acid, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium stearyl fumarate, titanium dioxide and is printed with edible black ink. In addition, the 100 mg tablet contains FD&C Red #40, the 150 mg tablet contains FD&C Blue #1 and D&C Yellow #10 Lake and the 200 mg tablet contains D&C Yellow #10 Lake. FDA approved dissolution test specifications differ from USP.</Description>
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<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:. As oral formulation for the:. · Treatment of schizophrenia. (1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2). · Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. As Olanzapine and Fluoxetine in Combination for the: Treatment of depressive episodes associated with bipolar I disorder. (1.5) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax. Treatment of treatment resistant depression. (1.6) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg).</Description>
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<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:. As oral formulation for the:. · Treatment of schizophrenia. (1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2). · Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. As Olanzapine and Fluoxetine in Combination for the: Treatment of depressive episodes associated with bipolar I disorder. (1.5) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax. Treatment of treatment resistant depression. (1.6) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg).</Description>
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<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:. As oral formulation for the:. · Treatment of schizophrenia. (1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2). · Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. As Olanzapine and Fluoxetine in Combination for the: Treatment of depressive episodes associated with bipolar I disorder. (1.5) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax. Treatment of treatment resistant depression. (1.6) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg).</Description>
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<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:. As oral formulation for the:. · Treatment of schizophrenia. (1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2). · Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. As Olanzapine and Fluoxetine in Combination for the: Treatment of depressive episodes associated with bipolar I disorder. (1.5) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax. Treatment of treatment resistant depression. (1.6) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg).</Description>
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<ProductNDC>35000-068</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Irish Spring Antibacterial Bar</ProprietaryName>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps eliminate bacteria on skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>35000-068-03</NDCCode>
<PackageDescription>3 CARTON in 1 CELLO PACK (35000-068-03) / 1 APPLICATOR in 1 CARTON / 104.8 g in 1 APPLICATOR</PackageDescription>
<NDC11Code>35000-0068-03</NDC11Code>
<ProductNDC>35000-068</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Irish Spring Antibacterial Bar</ProprietaryName>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps eliminate bacteria on skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>35000-068-06</NDCCode>
<PackageDescription>6 CARTON in 1 CELLO PACK (35000-068-06) / 1 APPLICATOR in 1 CARTON / 104.8 g in 1 APPLICATOR</PackageDescription>
<NDC11Code>35000-0068-06</NDC11Code>
<ProductNDC>35000-068</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Irish Spring Antibacterial Bar</ProprietaryName>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps eliminate bacteria on skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>35000-068-08</NDCCode>
<PackageDescription>8 CARTON in 1 CELLO PACK (35000-068-08) / 1 APPLICATOR in 1 CARTON / 104.8 g in 1 APPLICATOR</PackageDescription>
<NDC11Code>35000-0068-08</NDC11Code>
<ProductNDC>35000-068</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Irish Spring Antibacterial Bar</ProprietaryName>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps eliminate bacteria on skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42291-068-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (42291-068-30) </PackageDescription>
<NDC11Code>42291-0068-30</NDC11Code>
<ProductNDC>42291-068</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220412</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079022</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220412</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). ( 1.1).</IndicationAndUsage>
<Description>Atomoxetine HCl is a selective norepinephrine reuptake inhibitor. Atomoxetine HCl, USP is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)- N-methyl-3-phenyl-3-( o-tolyoxy)-propylamine hydrochloride. The chemical structure is:. C 17H 21NOHCl M.W. 291.82. Atomoxetine HCl, USP is a white to practically white powder, which has a solubility of 27.8 mg/mL in water. Atomoxetine Capsules USP are intended for oral administration only. Each capsule contains atomoxetine HCl, USP equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. The capsules also contain black iron oxide, gelatin, potassium hydroxide, pregelatinized corn starch, propylene glycol, shellac, sodium lauryl sulfate, strong ammonia solution, and titanium dioxide. Additionally the 18 mg and 60 mg capsules contain D&C yellow #10; the 25 mg, 40 mg, and 60 mg capsules contain FD&C blue #1; and the 80 mg and 100 mg capsules contain red iron oxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>43742-0068-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43742-0068-1)</PackageDescription>
<NDC11Code>43742-0068-01</NDC11Code>
<ProductNDC>43742-0068</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lymphoplus</ProprietaryName>
<NonProprietaryName>Trifolium Pratense, Lymph (suis), Spleen (suis), Conium Maculatum, Echinacea, Lycopodium Clavatum, Myrrha, Phytolacca Decandra, Selenium Metallicum, Silicea,</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120711</StartMarketingDate>
<EndMarketingDate>20190304</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Deseret Biologicals, Inc.</LabelerName>
<SubstanceName>TRIFOLIUM PRATENSE FLOWER; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; CONIUM MACULATUM FLOWERING TOP; ECHINACEA, UNSPECIFIED; LYCOPODIUM CLAVATUM SPORE; MYRRH; PHYTOLACCA AMERICANA ROOT; SELENIUM; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>3; 8; 8; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-03-05</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
</NDCList>