{
"NDC": [
{
"NDCCode": "17312-433-23",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (17312-433-23) / 20 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "17312-0433-23",
"ProductNDC": "17312-433",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus And Sinus",
"ProprietaryNameSuffix": "Mucus And Sinus Symptom Relief",
"NonProprietaryName": "Bryonia Alba, Hydrastis Canadensis, Kali Bichromicum, Natrum Muriaticum, Pulsatilla Pratensis, Silicea, Stannum Metallicum, Thuja Occidentalis, Zincum Gluconicum",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20240806",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "TRP Company",
"SubstanceName": "BRYONIA ALBA ROOT; ZINC GLUCONATE; THUJA OCCIDENTALIS LEAFY TWIG; TIN; SILICON DIOXIDE; PULSATILLA PRATENSIS; SODIUM CHLORIDE; POTASSIUM DICHROMATE; GOLDENSEAL",
"StrengthNumber": "15; 4; 12; 15; 15; 12; 6; 12; 12",
"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",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240806",
"SamplePackage": "N",
"IndicationAndUsage": "Uses*. According to homeopathic indications, these ingredients provide temporary relief from symptoms of mucus and sinus congestion.. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "17312-431-23",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (17312-431-23) / 20 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "17312-0431-23",
"ProductNDC": "17312-431",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Natural Relief Cold And Flu",
"ProprietaryNameSuffix": "Plus Zinc",
"NonProprietaryName": "Allium Cepa, Arsenicum Album, Bryonia Alba, Eupatorium Perfoliatum, Gelsemium Sempervirens, Natrum Muriaticum, Nux Vomica, Silicea, Sulphur, Zincum Gluconicum",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20240806",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "TRP Company",
"SubstanceName": "ALLIUM CEPA WHOLE; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED; SODIUM CHLORIDE; BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS WHOLE; EUPATORIUM PERFOLIATUM FLOWERING TOP; ARSENIC TRIOXIDE; SULFUR; ZINC GLUCONATE",
"StrengthNumber": "6; 12; 12; 6; 12; 6; 6; 12; 12; 4",
"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",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240806",
"SamplePackage": "N",
"IndicationAndUsage": "Uses*. According to homeopathic indications, these ingredients provide temporary relief from symptoms of cold and flu such as: Fever / chills Runny nose. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "17312-432-23",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (17312-432-23) / 20 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "17312-0432-23",
"ProductNDC": "17312-432",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Natural Relief Cough And Congestion",
"ProprietaryNameSuffix": "Cough And Congestion Symptom Relief",
"NonProprietaryName": "Antimonium Tartaricum, Coccus Cacti, Cuprum Metallicum, Drosera Rotundifolia, Echinacea Angustifolia, Kali Carbonicum, Mephitis Mephitica, Natrum Muriaticum, Rumex Crispus, Zincum Gluconicum",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20240806",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "TRP Company",
"SubstanceName": "ANTIMONY POTASSIUM TARTRATE; ZINC GLUCONATE; RUMEX CRISPUS ROOT; SODIUM CHLORIDE; MEPHITIS MEPHITIS ANAL GLAND FLUID; POTASSIUM CARBONATE; ECHINACEA ANGUSTIFOLIA; DROSERA ROTUNDIFOLIA; COPPER; PROTORTONIA CACTI",
"StrengthNumber": "6; 4; 6; 6; 12; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Copper Ion Absorption [PE], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240806",
"SamplePackage": "N",
"IndicationAndUsage": "Uses*. According to homeopathic indications, these ingredients provide temporary relief from symptoms of cough and congestion.. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "0065-0800-50",
"PackageDescription": "1 KIT in 1 PACKAGE (0065-0800-50) * 480 mL in 1 BOTTLE, GLASS * 20 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00065-0800-50",
"ProductNDC": "0065-0800",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bss Plus",
"NonProprietaryName": "Balanced Salt Solution Enriched With Bicarbonate, Dextrose, And Glutathione",
"DosageFormName": "KIT",
"StartMarketingDate": "19820628",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018469",
"LabelerName": "Alcon Laboratories, Inc.",
"Status": "Active",
"LastUpdate": "2024-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19820628",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: BSS PLUS is indicated for use as an intraocular irrigating solution during intraocular surgical procedures involving perfusion of the eye.",
"Description": "DESCRIPTION: BSS PLUS® is a sterile intraocular irrigating solution for use during all intraocular surgical procedures, including those requiring a relatively long intraocular perfusion time (e.g., pars plana vitrectomy, phacoemulsification, extracapsular cataract extraction/lens aspiration, anterior segment reconstruction, etc.). The solution does not contain a preservative and should be prepared just prior to use in surgery. Part I: Part I is a sterile 480 mL solution in a 500 mL single-dose bottle to which the Part II concentrate is added. Each mL of Part I contains: sodium chloride 7.44 mg, potassium chloride 0.395 mg, dibasic sodium phosphate 0.433 mg, sodium bicarbonate 2.19 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection. Part II: Part II is a sterile concentrate in a 20 mL single-dose vial for addition to Part I. Each mL of Part II contains: calcium chloride dihydrate 3.85 mg, magnesium chloride hexahydrate 5 mg, dextrose 23 mg, glutathione disulfide (oxidized glutathione) 4.6 mg, in water for injection. After addition of BSS PLUS Part II to the Part I bottle, each mL of the reconstituted product contains: sodium chloride 7.14 mg, potassium chloride 0.38 mg, calcium chloride dihydrate 0.154 mg, magnesium chloride hexahydrate 0.2 mg, dibasic sodium phosphate 0.42 mg, sodium bicarbonate 2.1 mg, dextrose 0.92 mg, glutathione disulfide (oxidized glutathione) 0.184 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection. The reconstituted product has a pH of approximately 7.4. Osmolality is approximately 305 mOsm."
},
{
"NDCCode": "0065-0800-94",
"PackageDescription": "1 KIT in 1 PACKAGE (0065-0800-94) * 480 mL in 1 BAG * 20 mL in 1 VIAL, GLASS",
"NDC11Code": "00065-0800-94",
"ProductNDC": "0065-0800",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bss Plus",
"NonProprietaryName": "Balanced Salt Solution Enriched With Bicarbonate, Dextrose, And Glutathione",
"DosageFormName": "KIT",
"StartMarketingDate": "20130620",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018469",
"LabelerName": "Alcon Laboratories, Inc.",
"Status": "Active",
"LastUpdate": "2024-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130620",
"SamplePackage": "N",
"IndicationAndUsage": "BSS PLUS solution is indicated for use as an intraocular irrigating solution during intraocular surgical procedures involving perfusion of the eye.",
"Description": "BSS PLUS® is a sterile intraocular irrigating solution for use during all intraocular surgical procedures, including those requiring a relatively long intraocular perfusion time (e.g., pars plana vitrectomy, phacoemulsification, extra capsular cataract extraction/lens aspiration, anterior segment reconstruction, etc.). The solution does not contain a preservative and should be prepared just prior to use in surgery.Part I: Part I is a sterile 480 mL solution in a 500 mL single-dose bag to which the Part II concentrate is added. Each mL of Part I contains: sodium chloride 7.44 mg, potassium chloride 0.395 mg, dibasic sodium phosphate 0.433 mg, sodium bicarbonate 2.19 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection.Part II: Part II is a sterile concentrate in a 20 mL single-dose vial for addition to Part I. Each mL of Part II contains: calcium chloride dihydrate 3.85 mg, magnesium chloride hexahydrate 5 mg, dextrose 23 mg, glutathione disulfide (oxidized glutathione) 4.6 mg, in water for injection.After addition of BSS PLUS solution Part II to the Part I bag, each mL of the reconstituted product contains: sodium chloride 7.14 mg, potassium chloride 0.38 mg, calcium chloride dihydrate 0.154 mg, magnesium chloride hexahydrate 0.2 mg, dibasic sodium phosphate 0.42 mg, sodium bicarbonate 2.1 mg, dextrose 0.92 mg, glutathione disulfide (oxidized glutathione) 0.184 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection.The reconstituted product has a pH of approximately 7.4. Osmolality is approximately 305 mOsm."
},
{
"NDCCode": "12784-433-59",
"PackageDescription": "59 kg in 1 DRUM (12784-433-59) ",
"NDC11Code": "12784-0433-59",
"ProductNDC": "12784-433",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Aluminum Hydroxide",
"DosageFormName": "GEL",
"StartMarketingDate": "20200123",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "SPI PHARMA",
"SubstanceName": "ALUMINUM HYDROXIDE",
"StrengthNumber": "76",
"StrengthUnit": "kg/100kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "23-JAN-20"
},
{
"NDCCode": "14335-433-01",
"PackageDescription": "12 kg in 1 DRUM (14335-433-01) ",
"NDC11Code": "14335-0433-01",
"ProductNDC": "14335-433",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Apremilast",
"DosageFormName": "POWDER",
"StartMarketingDate": "20230815",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Hainan Poly Pharm. Co., Ltd.",
"SubstanceName": "APREMILAST",
"StrengthNumber": "12",
"StrengthUnit": "kg/12kg",
"Status": "Unfinished",
"LastUpdate": "2023-12-07",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "15-AUG-23"
},
{
"NDCCode": "27241-204-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (27241-204-30) ",
"NDC11Code": "27241-0204-30",
"ProductNDC": "27241-204",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brexpiprazole",
"NonProprietaryName": "Brexpiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213718",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "BREXPIPRAZOLE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2023-02-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230203",
"SamplePackage": "N",
"IndicationAndUsage": "Brexpiprazole tablets are indicated for: 1 Adjunctive treatment of major depressive disorder (MDD) in adults., 2 Treatment of schizophrenia in adults.",
"Description": "Brexpiprazole, an atypical antipsychotic, is available as brexpiprazole tablets. Brexpiprazole is 7-{4-[4-(1- Benzothiophen-4-yl)piperazin-1-yl]butoxy}quinolin-2(1H)-one. The molecular formula is C25H27N3O2S and its molecular weight is 433.57. The chemical structure is. Brexpiprazole tablets are for oral administration and are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths. Inactive ingredients include microcrystalline cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, talc, propylene glycol, polyethylene glycol. Colorants includes titanium dioxide, iron oxide red (0.25 mg and 3 mg), FD&C Yellow #6 (0.5 mg), iron oxide yellow (1 mg, 2 mg and 3 mg), FD&C Blue #2 (2 mg)."
},
{
"NDCCode": "27241-205-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (27241-205-30) ",
"NDC11Code": "27241-0205-30",
"ProductNDC": "27241-205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brexpiprazole",
"NonProprietaryName": "Brexpiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213718",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "BREXPIPRAZOLE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2023-02-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230203",
"SamplePackage": "N",
"IndicationAndUsage": "Brexpiprazole tablets are indicated for: 1 Adjunctive treatment of major depressive disorder (MDD) in adults., 2 Treatment of schizophrenia in adults.",
"Description": "Brexpiprazole, an atypical antipsychotic, is available as brexpiprazole tablets. Brexpiprazole is 7-{4-[4-(1- Benzothiophen-4-yl)piperazin-1-yl]butoxy}quinolin-2(1H)-one. The molecular formula is C25H27N3O2S and its molecular weight is 433.57. The chemical structure is. Brexpiprazole tablets are for oral administration and are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths. Inactive ingredients include microcrystalline cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, talc, propylene glycol, polyethylene glycol. Colorants includes titanium dioxide, iron oxide red (0.25 mg and 3 mg), FD&C Yellow #6 (0.5 mg), iron oxide yellow (1 mg, 2 mg and 3 mg), FD&C Blue #2 (2 mg)."
},
{
"NDCCode": "27241-206-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (27241-206-30) ",
"NDC11Code": "27241-0206-30",
"ProductNDC": "27241-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brexpiprazole",
"NonProprietaryName": "Brexpiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213718",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "BREXPIPRAZOLE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2023-02-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230203",
"SamplePackage": "N",
"IndicationAndUsage": "Brexpiprazole tablets are indicated for: 1 Adjunctive treatment of major depressive disorder (MDD) in adults., 2 Treatment of schizophrenia in adults.",
"Description": "Brexpiprazole, an atypical antipsychotic, is available as brexpiprazole tablets. Brexpiprazole is 7-{4-[4-(1- Benzothiophen-4-yl)piperazin-1-yl]butoxy}quinolin-2(1H)-one. The molecular formula is C25H27N3O2S and its molecular weight is 433.57. The chemical structure is. Brexpiprazole tablets are for oral administration and are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths. Inactive ingredients include microcrystalline cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, talc, propylene glycol, polyethylene glycol. Colorants includes titanium dioxide, iron oxide red (0.25 mg and 3 mg), FD&C Yellow #6 (0.5 mg), iron oxide yellow (1 mg, 2 mg and 3 mg), FD&C Blue #2 (2 mg)."
},
{
"NDCCode": "27241-207-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (27241-207-30) ",
"NDC11Code": "27241-0207-30",
"ProductNDC": "27241-207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brexpiprazole",
"NonProprietaryName": "Brexpiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213718",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "BREXPIPRAZOLE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2023-02-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230203",
"SamplePackage": "N",
"IndicationAndUsage": "Brexpiprazole tablets are indicated for: 1 Adjunctive treatment of major depressive disorder (MDD) in adults., 2 Treatment of schizophrenia in adults.",
"Description": "Brexpiprazole, an atypical antipsychotic, is available as brexpiprazole tablets. Brexpiprazole is 7-{4-[4-(1- Benzothiophen-4-yl)piperazin-1-yl]butoxy}quinolin-2(1H)-one. The molecular formula is C25H27N3O2S and its molecular weight is 433.57. The chemical structure is. Brexpiprazole tablets are for oral administration and are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths. Inactive ingredients include microcrystalline cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, talc, propylene glycol, polyethylene glycol. Colorants includes titanium dioxide, iron oxide red (0.25 mg and 3 mg), FD&C Yellow #6 (0.5 mg), iron oxide yellow (1 mg, 2 mg and 3 mg), FD&C Blue #2 (2 mg)."
},
{
"NDCCode": "27241-208-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (27241-208-30) ",
"NDC11Code": "27241-0208-30",
"ProductNDC": "27241-208",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brexpiprazole",
"NonProprietaryName": "Brexpiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213718",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "BREXPIPRAZOLE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2023-02-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230203",
"SamplePackage": "N",
"IndicationAndUsage": "Brexpiprazole tablets are indicated for: 1 Adjunctive treatment of major depressive disorder (MDD) in adults., 2 Treatment of schizophrenia in adults.",
"Description": "Brexpiprazole, an atypical antipsychotic, is available as brexpiprazole tablets. Brexpiprazole is 7-{4-[4-(1- Benzothiophen-4-yl)piperazin-1-yl]butoxy}quinolin-2(1H)-one. The molecular formula is C25H27N3O2S and its molecular weight is 433.57. The chemical structure is. Brexpiprazole tablets are for oral administration and are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths. Inactive ingredients include microcrystalline cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, talc, propylene glycol, polyethylene glycol. Colorants includes titanium dioxide, iron oxide red (0.25 mg and 3 mg), FD&C Yellow #6 (0.5 mg), iron oxide yellow (1 mg, 2 mg and 3 mg), FD&C Blue #2 (2 mg)."
},
{
"NDCCode": "27241-209-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (27241-209-30) ",
"NDC11Code": "27241-0209-30",
"ProductNDC": "27241-209",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brexpiprazole",
"NonProprietaryName": "Brexpiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213718",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "BREXPIPRAZOLE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2023-02-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230203",
"SamplePackage": "N",
"IndicationAndUsage": "Brexpiprazole tablets are indicated for: 1 Adjunctive treatment of major depressive disorder (MDD) in adults., 2 Treatment of schizophrenia in adults.",
"Description": "Brexpiprazole, an atypical antipsychotic, is available as brexpiprazole tablets. Brexpiprazole is 7-{4-[4-(1- Benzothiophen-4-yl)piperazin-1-yl]butoxy}quinolin-2(1H)-one. The molecular formula is C25H27N3O2S and its molecular weight is 433.57. The chemical structure is. Brexpiprazole tablets are for oral administration and are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths. Inactive ingredients include microcrystalline cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, talc, propylene glycol, polyethylene glycol. Colorants includes titanium dioxide, iron oxide red (0.25 mg and 3 mg), FD&C Yellow #6 (0.5 mg), iron oxide yellow (1 mg, 2 mg and 3 mg), FD&C Blue #2 (2 mg)."
},
{
"NDCCode": "55111-302-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (55111-302-05) ",
"NDC11Code": "55111-0302-05",
"ProductNDC": "55111-302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130726",
"EndMarketingDate": "20250331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202723",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "23",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130726",
"EndMarketingDatePackage": "20250331",
"SamplePackage": "N",
"IndicationAndUsage": "Donepezil hydrochloride tablets are indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.",
"Description": "Donepezil hydrochloride monohydrate USP is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride monohydrate USP is commonly referred to in the pharmacological literature as E2020. It has an molecular formula of C24H29NO3HCl.H2O and a molecular weight of 433.95. Donepezil hydrochloride monohydrate USP is a off-white to white crystalline powder and is soluble in chloroform, water and in glacial aceticacid, slightly soluble in alcohol and acetonitrile, practically insoluble in ethyl acetate and n-Hexane. Donepezil hydrochloride tablets, USP are available for oral administration in film-coated tablets containing 23 mg of donepezil hydrochloride monohydrate USP. Inactive ingredients are hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate and methacrylic acid copolymer. The film coating includes iron oxide red, iron oxide yellow and Opadry OY-58900 White contains hypromellose, polyethylene glycol and titanium dioxide."
},
{
"NDCCode": "55111-302-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (55111-302-10) ",
"NDC11Code": "55111-0302-10",
"ProductNDC": "55111-302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130726",
"EndMarketingDate": "20250331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202723",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "23",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130726",
"EndMarketingDatePackage": "20250331",
"SamplePackage": "N",
"IndicationAndUsage": "Donepezil hydrochloride tablets are indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.",
"Description": "Donepezil hydrochloride monohydrate USP is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride monohydrate USP is commonly referred to in the pharmacological literature as E2020. It has an molecular formula of C24H29NO3HCl.H2O and a molecular weight of 433.95. Donepezil hydrochloride monohydrate USP is a off-white to white crystalline powder and is soluble in chloroform, water and in glacial aceticacid, slightly soluble in alcohol and acetonitrile, practically insoluble in ethyl acetate and n-Hexane. Donepezil hydrochloride tablets, USP are available for oral administration in film-coated tablets containing 23 mg of donepezil hydrochloride monohydrate USP. Inactive ingredients are hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate and methacrylic acid copolymer. The film coating includes iron oxide red, iron oxide yellow and Opadry OY-58900 White contains hypromellose, polyethylene glycol and titanium dioxide."
},
{
"NDCCode": "55111-302-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (55111-302-30) ",
"NDC11Code": "55111-0302-30",
"ProductNDC": "55111-302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250820",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202723",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "23",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250820",
"SamplePackage": "N",
"IndicationAndUsage": "Donepezil hydrochloride tablets are indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.",
"Description": "Donepezil hydrochloride monohydrate USP is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride monohydrate. Donepezil hydrochloride monohydrate USP is commonly referred to in the pharmacological literature as E2020. It has an molecular formula of C24H29NO3HCl.H2O and a molecular weight of 433.95. Donepezil hydrochloride monohydrate USP is a off-white to white crystalline powder and is soluble in chloroform, water and in glacial aceticacid, slightly soluble in alcohol and acetonitrile, practically insoluble in ethyl acetate and n-Hexane. Donepezil hydrochloride tablets, USP are available for oral administration in film-coated tablets containing 23 mg of donepezil hydrochloride monohydrate USP. Inactive ingredients are hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate and methacrylic acid copolymer. The film coating includes iron oxide red, iron oxide yellow and Opadry OY-58900 White contains hypromellose, polyethylene glycol and titanium dioxide."
},
{
"NDCCode": "55111-302-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (55111-302-90) ",
"NDC11Code": "55111-0302-90",
"ProductNDC": "55111-302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250820",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202723",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "23",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250820",
"SamplePackage": "N",
"IndicationAndUsage": "Donepezil hydrochloride tablets are indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.",
"Description": "Donepezil hydrochloride monohydrate USP is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride monohydrate. Donepezil hydrochloride monohydrate USP is commonly referred to in the pharmacological literature as E2020. It has an molecular formula of C24H29NO3HCl.H2O and a molecular weight of 433.95. Donepezil hydrochloride monohydrate USP is a off-white to white crystalline powder and is soluble in chloroform, water and in glacial aceticacid, slightly soluble in alcohol and acetonitrile, practically insoluble in ethyl acetate and n-Hexane. Donepezil hydrochloride tablets, USP are available for oral administration in film-coated tablets containing 23 mg of donepezil hydrochloride monohydrate USP. Inactive ingredients are hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate and methacrylic acid copolymer. The film coating includes iron oxide red, iron oxide yellow and Opadry OY-58900 White contains hypromellose, polyethylene glycol and titanium dioxide."
},
{
"NDCCode": "60687-438-01",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-438-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-438-11) ",
"NDC11Code": "60687-0438-01",
"ProductNDC": "60687-438",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mycophenolate Mofetil",
"NonProprietaryName": "Mycophenolate Mofetil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090456",
"LabelerName": "American Health Packaging",
"SubstanceName": "MYCOPHENOLATE MOFETIL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190614",
"SamplePackage": "N",
"IndicationAndUsage": "Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.",
"Description": "Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C 23H 31NO 7, a molecular weight of 433.50, and the following structural formula:. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. Mycophenolate mofetil is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of MMF. Inactive ingredients in mycophenolate mofetil capsules, USP 250 mg include croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone (K-30). The capsule shells contain FD&C red # 3, gelatin, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. Inactive ingredients in mycophenolate mofetil tablets, USP 500 mg include croscarmellose sodium, magnesium stearate (Vegetable), microcrystalline cellulose, opadry brown, povidone [K-30]. The opadry brown contains FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, hypromellose, iron oxide red, polyethylene glycol and titanium dioxide."
},
{
"NDCCode": "68382-096-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (68382-096-01) ",
"NDC11Code": "68382-0096-01",
"ProductNDC": "68382-096",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxychloroquine Sulfate",
"NonProprietaryName": "Hydroxychloroquine Sulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040657",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "HYDROXYCHLOROQUINE SULFATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC], Antirheumatic Agent [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080103",
"SamplePackage": "N",
"IndicationAndUsage": "Hydroxychloroquine sulfate tablets is an antimalarial and antirheumatic indicated for the: 1 Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivaxin adult and pediatric patients. (1.1), 2 Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1), 3 Treatment of rheumatoid arthritis in adults. (1.2), 4 Treatment of systemic lupus erythematosus in adults. (1.3), 5 Treatment of chronic discoid lupus erythematosus in adults. (1.4).",
"Description": "Hydroxychloroquine sulfate tablet, USP is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4-quinolyl) amino]pentyl] ethylamino] ethanol sulfate (1:1) with the molecular formula C18H26ClN3OH2SO4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is. Hydroxychloroquine sulfate is a white or practically white, crystalline powder, freely soluble in water; practically insoluble in alcohol, chloroform, and in ether. Each hydroxychloroquine sulfate tablet intended for oral administration contains 200 mg of hydroxychloroquine sulfate, USP equivalent to 155 mg base. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate dihydrate, magnesium stearate, pregelatinized starch, polyethylene glycol, polyvinyl alcohol, starch, talc and titanium dioxide."
},
{
"NDCCode": "68382-096-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (68382-096-05) ",
"NDC11Code": "68382-0096-05",
"ProductNDC": "68382-096",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxychloroquine Sulfate",
"NonProprietaryName": "Hydroxychloroquine Sulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040657",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "HYDROXYCHLOROQUINE SULFATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC], Antirheumatic Agent [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080103",
"SamplePackage": "N",
"IndicationAndUsage": "Hydroxychloroquine sulfate tablets is an antimalarial and antirheumatic indicated for the: 1 Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivaxin adult and pediatric patients. (1.1), 2 Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1), 3 Treatment of rheumatoid arthritis in adults. (1.2), 4 Treatment of systemic lupus erythematosus in adults. (1.3), 5 Treatment of chronic discoid lupus erythematosus in adults. (1.4).",
"Description": "Hydroxychloroquine sulfate tablet, USP is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4-quinolyl) amino]pentyl] ethylamino] ethanol sulfate (1:1) with the molecular formula C18H26ClN3OH2SO4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is. Hydroxychloroquine sulfate is a white or practically white, crystalline powder, freely soluble in water; practically insoluble in alcohol, chloroform, and in ether. Each hydroxychloroquine sulfate tablet intended for oral administration contains 200 mg of hydroxychloroquine sulfate, USP equivalent to 155 mg base. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate dihydrate, magnesium stearate, pregelatinized starch, polyethylene glycol, polyvinyl alcohol, starch, talc and titanium dioxide."
},
{
"NDCCode": "68382-096-77",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (68382-096-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68382-096-30) ",
"NDC11Code": "68382-0096-77",
"ProductNDC": "68382-096",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxychloroquine Sulfate",
"NonProprietaryName": "Hydroxychloroquine Sulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040657",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "HYDROXYCHLOROQUINE SULFATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC], Antirheumatic Agent [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080103",
"SamplePackage": "N",
"IndicationAndUsage": "Hydroxychloroquine sulfate tablets is an antimalarial and antirheumatic indicated for the: 1 Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivaxin adult and pediatric patients. (1.1), 2 Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1), 3 Treatment of rheumatoid arthritis in adults. (1.2), 4 Treatment of systemic lupus erythematosus in adults. (1.3), 5 Treatment of chronic discoid lupus erythematosus in adults. (1.4).",
"Description": "Hydroxychloroquine sulfate tablet, USP is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4-quinolyl) amino]pentyl] ethylamino] ethanol sulfate (1:1) with the molecular formula C18H26ClN3OH2SO4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is. Hydroxychloroquine sulfate is a white or practically white, crystalline powder, freely soluble in water; practically insoluble in alcohol, chloroform, and in ether. Each hydroxychloroquine sulfate tablet intended for oral administration contains 200 mg of hydroxychloroquine sulfate, USP equivalent to 155 mg base. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate dihydrate, magnesium stearate, pregelatinized starch, polyethylene glycol, polyvinyl alcohol, starch, talc and titanium dioxide."
},
{
"NDCCode": "69842-433-05",
"PackageDescription": "1 KIT in 1 CARTON (69842-433-05) * 1 CONTAINER in 1 CARTON (59779-190-03) > 24 LOZENGE in 1 CONTAINER * 2 CONTAINER in 1 CARTON (59779-873-04) > 24 LOZENGE in 1 CONTAINER",
"NDC11Code": "69842-0433-05",
"ProductNDC": "69842-433",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "KIT",
"StartMarketingDate": "20180409",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090711",
"LabelerName": "CVS Pharmacy",
"Status": "Deprecated",
"LastUpdate": "2021-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180409",
"SamplePackage": "N"
},
{
"NDCCode": "70518-2835-0",
"PackageDescription": "100 POUCH in 1 BOX (70518-2835-0) / 1 CAPSULE in 1 POUCH (70518-2835-1) ",
"NDC11Code": "70518-2835-00",
"ProductNDC": "70518-2835",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mycophenolate Mofetil",
"NonProprietaryName": "Mycophenolate Mofetil",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200818",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090253",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "MYCOPHENOLATE MOFETIL",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200818",
"SamplePackage": "N",
"IndicationAndUsage": "Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)] , heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.",
"Description": "Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1, 3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C 23H 31NO 7, a molecular weight of 433.50, and the following structural formula:. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. Mycophenolate mofetil is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of MMF. Inactive ingredients in mycophenolate mofetil 250 mg capsules include croscarmellose sodium, magnesium stearate, povidone (K-90) microcrystalline cellulose, hydroxy propyl cellulose and talc. The capsule shells contain FD&C blue #2, gelatin, red iron oxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. The imprinting ink contains shellac, iron oxide black and potassium hydroxide. Inactive ingredients in mycophenolate mofetil 500 mg tablets include iron oxide black, croscarmellose sodium, FD&C blue #2 aluminum Lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone (K-90), iron oxide red, talc, and titanium dioxide. Mycophenolate Mofetil Tablets meets USP Dissolution Test 3 and Mycophenolate Mofetil Capsules meets USP Dissolution Test 2."
},
{
"NDCCode": "71335-2933-1",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (71335-2933-1) ",
"NDC11Code": "71335-2933-01",
"ProductNDC": "71335-2933",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluvastatin",
"NonProprietaryName": "Fluvastatin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120705",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078407",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "FLUVASTATIN SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251021",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other non-pharmacologic measures alone has been inadequate.",
"Description": "Fluvastatin sodium, USP is a water-soluble cholesterol lowering agent which acts through the inhibition of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase. Fluvastatin sodium, USP is [R*,S*-(E)]-(±)-7-[3-(4-fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]-3,5-dihydroxy-6-heptenoic acid, monosodium salt. Its structural formula is. C24H25FNNaO4 M.W. 433.45. This molecular entity is the first entirely synthetic HMG-CoA reductase inhibitor, and is in part structurally distinct from the fungal derivatives of this therapeutic class. Fluvastatin sodium, USP (hydrated form) is a white to pale yellow, brownish-pale yellow, or reddish-pale yellow, hygroscopic powder soluble in water, ethanol, and methanol. Fluvastatin Capsules, USP contain fluvastatin sodium, USP (hydrated form), equivalent to 20 mg or 40 mg of fluvastatin, for oral administration. Active Ingredient: fluvastatin sodium, USP (hydrated form). Inactive Ingredients: ammonium hydroxide, black iron oxide, colloidal silicon dioxide, crospovidone, gelatin, lactose monohydrate, magnesium stearate, propylene glycol, red iron oxide, shellac, titanium dioxide, and yellow iron oxide."
},
{
"NDCCode": "72189-433-09",
"PackageDescription": "9 TABLET, FILM COATED in 1 BOTTLE (72189-433-09) ",
"NDC11Code": "72189-0433-09",
"ProductNDC": "72189-433",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sumatriptan Succinate",
"NonProprietaryName": "Sumatriptan Succinate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078295",
"LabelerName": "Direct_Rx",
"SubstanceName": "SUMATRIPTAN SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230313",
"SamplePackage": "N",
"IndicationAndUsage": "Sumatriptan succinate tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use:. Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan succinate tablets, reconsider the diagnosis of migraine before sumatriptan succinate tablets are administered to treat any subsequent attacks. Sumatriptan succinate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of sumatriptan succinate tablets have not been established for cluster headache.",
"Description": "Sumatriptan succinate tablets contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure. [chemical-structure]. The molecular formula is C14H21N3O2S·C4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan succinate tablet for oral administration contains 35 mg, 70 mg, or 140 mg of sumatriptan succinate, USP equivalent to 25 mg, 50 mg, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C Red # 27 aluminum lake (100 mg only), dibasic calcium phosphate, hypromellose, iron oxide red (100 mg only), magnesium stearate, microcrystalline cellulose, polyethylene glycol (25 mg & 50 mg only), polysorbate 80 (25 mg & 50 mg only) propylene glycol (100 mg only), talc and titanium dioxide."
},
{
"NDCCode": "17312-001-11",
"PackageDescription": "1 BOTTLE, DROPPER in 1 PACKAGE (17312-001-11) > 15 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "17312-0001-11",
"ProductNDC": "17312-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ring Relief",
"NonProprietaryName": "Arnica Montana, Calcium Sulfide, Hypericum Perforatum, Lycopodium Clavatum Spore, Thiosinaminum, Mercurius Solubilis, Salicylic Acid, Silicon Dioxide, Allylthiourea",
"DosageFormName": "LIQUID",
"RouteName": "AURICULAR (OTIC)",
"StartMarketingDate": "20060601",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "TRP Company",
"SubstanceName": "ARNICA MONTANA; CALCIUM SULFIDE; HYPERICUM PERFORATUM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SALICYLIC ACID; SILICON DIOXIDE; ALLYLTHIOUREA",
"StrengthNumber": "6; 13; 6; 12; 13; 6; 13; 6",
"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",
"Status": "Deprecated",
"LastUpdate": "2018-02-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "17312-001-15",
"PackageDescription": "1 BOTTLE, DROPPER in 1 PACKAGE (17312-001-15) / 10 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "17312-0001-15",
"ProductNDC": "17312-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ring Relief",
"NonProprietaryName": "Arnica Montana, Calcium Sulfide, Hypericum Perforatum, Lycopodium Clavatum Spore, Thiosinaminum, Mercurius Solubilis, Salicylic Acid, Silicon Dioxide, Allylthiourea",
"DosageFormName": "LIQUID",
"RouteName": "AURICULAR (OTIC)",
"StartMarketingDate": "20060601",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "TRP Company",
"SubstanceName": "ARNICA MONTANA; CALCIUM SULFIDE; HYPERICUM PERFORATUM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SALICYLIC ACID; SILICON DIOXIDE; ALLYLTHIOUREA",
"StrengthNumber": "6; 13; 6; 12; 13; 6; 13; 6",
"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",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150505",
"SamplePackage": "N",
"IndicationAndUsage": "Uses:* According to homeopathic indications, these ingredients temporarily relieve Tinnitus symptoms such as: Ringing Buzzing Roaring Nerve and Noise Sensitivity Pounding Discomfort Wax buildup after serious causes have been ruled out by a physician. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "17312-002-11",
"PackageDescription": "1 BOTTLE, DROPPER in 1 PACKAGE (17312-002-11) > 15 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "17312-0002-11",
"ProductNDC": "17312-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Blur Relief",
"NonProprietaryName": "Jacobaea Maritima, Calcium Fluoride, Conium Maculatum Flowering Top, Euphrasia Stricta, Gelsemium Sempervirens Root, Sodium Chloride, Ruta Graveolens Flowering Top",
"DosageFormName": "LIQUID",
"RouteName": "INTRAOCULAR",
"StartMarketingDate": "20060601",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "TRP Company",
"SubstanceName": "CALCIUM FLUORIDE; CONIUM MACULATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; JACOBAEA MARITIMA; RUTA GRAVEOLENS FLOWERING TOP; SODIUM CHLORIDE",
"StrengthNumber": "13; 6; 6; 6; 5; 6; 6",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20060601",
"SamplePackage": "N",
"IndicationAndUsage": "Uses:*. According to homeopathic indications these ingredients provide temporary relief from symptoms such as: Blurry Vision Dry, Red & Tired Eyes Poor Night Vision (Glare) Difficulty reading after serious causes have been ruled out by a physician. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "17312-003-12",
"PackageDescription": "1 BOTTLE in 1 PACKAGE (17312-003-12) > 60 TABLET, MULTILAYER in 1 BOTTLE",
"NDC11Code": "17312-0003-12",
"ProductNDC": "17312-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ring Relief",
"NonProprietaryName": "Potassium Sulfate, Salicylic Acid, Silicon Dioxide, Calcium Sulfate Anhydrous, Quinine Sulfate, Allylthiourea",
"DosageFormName": "TABLET, MULTILAYER",
"RouteName": "ORAL",
"StartMarketingDate": "20060601",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "TRP Company",
"SubstanceName": "POTASSIUM SULFATE; SALICYLIC ACID; SILICON DIOXIDE; CALCIUM SULFATE ANHYDROUS; QUININE SULFATE; ALLYLTHIOUREA; CITRUS BIOFLAVONOIDS; GINKGO; THIAMINE; RIBOFLAVIN; NIACINAMIDE; PANTOTHENIC ACID; PYRIDOXINE; CYANOCOBALAMIN; BIOTIN; FOLIC ACID; INOSITOL; ZINC PICOLINATE; ASCORBIC ACID",
"StrengthNumber": "6; 6; 6; 6; 12; 6; 300; 30; .5; .5; 10; 2.5; .5; 200; 100; 200; 37.5; 7.5; 150",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "According to homeopathic indications these ingredients provide temporary relief from symptoms of Tinnitus such as: - Ringing - Buzzing - Noises in ears - Pain and Discomfort."
},
{
"NDCCode": "17312-004-12",
"PackageDescription": "1 BOTTLE in 1 PACKAGE (17312-004-12) > 60 TABLET, MULTILAYER in 1 BOTTLE",
"NDC11Code": "17312-0004-12",
"ProductNDC": "17312-004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Temporary Fibromyalgia Pain And Discomfort Relief",
"NonProprietaryName": "Aconitum Napellus, Atropa Belladonna, Causticum, Magnesium Phosphate, Dibasic, Strychnos Nux-vomica Seed, Toxicodendron Pubescens Leaf",
"DosageFormName": "TABLET, MULTILAYER",
"RouteName": "ORAL",
"StartMarketingDate": "20100201",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "TRP Company",
"SubstanceName": "ACONITUM NAPELLUS; ATROPA BELLADONNA; CAUSTICUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; MAGNESIUM ASCORBATE; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE; MAGNESIUM ASCORBATE; MAGNESIUM OXIDE; SELENIUM; SEDUM ROSEUM ROOT",
"StrengthNumber": "6; 6; 6; 6; 6; 6; 200; 1; 1; 20; 1; 400; 400; 200; 5; 75; 75; 100; 200",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "According to homeopathic indications these ingredients provide temporary relief from symptoms of Fibromyalgia such as: - Muscle Pain - Fatigue - Nerve/Soft Tissue Pain - Headache - Multiple Tender Points."
}
]
}
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<NDCList>
<NDC>
<NDCCode>17312-433-23</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (17312-433-23) / 20 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>17312-0433-23</NDC11Code>
<ProductNDC>17312-433</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucus And Sinus</ProprietaryName>
<ProprietaryNameSuffix>Mucus And Sinus Symptom Relief</ProprietaryNameSuffix>
<NonProprietaryName>Bryonia Alba, Hydrastis Canadensis, Kali Bichromicum, Natrum Muriaticum, Pulsatilla Pratensis, Silicea, Stannum Metallicum, Thuja Occidentalis, Zincum Gluconicum</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240806</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>TRP Company</LabelerName>
<SubstanceName>BRYONIA ALBA ROOT; ZINC GLUCONATE; THUJA OCCIDENTALIS LEAFY TWIG; TIN; SILICON DIOXIDE; PULSATILLA PRATENSIS; SODIUM CHLORIDE; POTASSIUM DICHROMATE; GOLDENSEAL</SubstanceName>
<StrengthNumber>15; 4; 12; 15; 15; 12; 6; 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</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240806</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses*. According to homeopathic indications, these ingredients provide temporary relief from symptoms of mucus and sinus congestion.. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17312-431-23</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (17312-431-23) / 20 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>17312-0431-23</NDC11Code>
<ProductNDC>17312-431</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Natural Relief Cold And Flu</ProprietaryName>
<ProprietaryNameSuffix>Plus Zinc</ProprietaryNameSuffix>
<NonProprietaryName>Allium Cepa, Arsenicum Album, Bryonia Alba, Eupatorium Perfoliatum, Gelsemium Sempervirens, Natrum Muriaticum, Nux Vomica, Silicea, Sulphur, Zincum Gluconicum</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240806</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>TRP Company</LabelerName>
<SubstanceName>ALLIUM CEPA WHOLE; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED; SODIUM CHLORIDE; BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS WHOLE; EUPATORIUM PERFOLIATUM FLOWERING TOP; ARSENIC TRIOXIDE; SULFUR; ZINC GLUCONATE</SubstanceName>
<StrengthNumber>6; 12; 12; 6; 12; 6; 6; 12; 12; 4</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>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240806</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses*. According to homeopathic indications, these ingredients provide temporary relief from symptoms of cold and flu such as: Fever / chills Runny nose. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17312-432-23</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (17312-432-23) / 20 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>17312-0432-23</NDC11Code>
<ProductNDC>17312-432</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Natural Relief Cough And Congestion</ProprietaryName>
<ProprietaryNameSuffix>Cough And Congestion Symptom Relief</ProprietaryNameSuffix>
<NonProprietaryName>Antimonium Tartaricum, Coccus Cacti, Cuprum Metallicum, Drosera Rotundifolia, Echinacea Angustifolia, Kali Carbonicum, Mephitis Mephitica, Natrum Muriaticum, Rumex Crispus, Zincum Gluconicum</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240806</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>TRP Company</LabelerName>
<SubstanceName>ANTIMONY POTASSIUM TARTRATE; ZINC GLUCONATE; RUMEX CRISPUS ROOT; SODIUM CHLORIDE; MEPHITIS MEPHITIS ANAL GLAND FLUID; POTASSIUM CARBONATE; ECHINACEA ANGUSTIFOLIA; DROSERA ROTUNDIFOLIA; COPPER; PROTORTONIA CACTI</SubstanceName>
<StrengthNumber>6; 4; 6; 6; 12; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Copper Ion Absorption [PE], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240806</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses*. According to homeopathic indications, these ingredients provide temporary relief from symptoms of cough and congestion.. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0065-0800-50</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (0065-0800-50) * 480 mL in 1 BOTTLE, GLASS * 20 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00065-0800-50</NDC11Code>
<ProductNDC>0065-0800</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bss Plus</ProprietaryName>
<NonProprietaryName>Balanced Salt Solution Enriched With Bicarbonate, Dextrose, And Glutathione</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19820628</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018469</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19820628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: BSS PLUS is indicated for use as an intraocular irrigating solution during intraocular surgical procedures involving perfusion of the eye.</IndicationAndUsage>
<Description>DESCRIPTION: BSS PLUS® is a sterile intraocular irrigating solution for use during all intraocular surgical procedures, including those requiring a relatively long intraocular perfusion time (e.g., pars plana vitrectomy, phacoemulsification, extracapsular cataract extraction/lens aspiration, anterior segment reconstruction, etc.). The solution does not contain a preservative and should be prepared just prior to use in surgery. Part I: Part I is a sterile 480 mL solution in a 500 mL single-dose bottle to which the Part II concentrate is added. Each mL of Part I contains: sodium chloride 7.44 mg, potassium chloride 0.395 mg, dibasic sodium phosphate 0.433 mg, sodium bicarbonate 2.19 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection. Part II: Part II is a sterile concentrate in a 20 mL single-dose vial for addition to Part I. Each mL of Part II contains: calcium chloride dihydrate 3.85 mg, magnesium chloride hexahydrate 5 mg, dextrose 23 mg, glutathione disulfide (oxidized glutathione) 4.6 mg, in water for injection. After addition of BSS PLUS Part II to the Part I bottle, each mL of the reconstituted product contains: sodium chloride 7.14 mg, potassium chloride 0.38 mg, calcium chloride dihydrate 0.154 mg, magnesium chloride hexahydrate 0.2 mg, dibasic sodium phosphate 0.42 mg, sodium bicarbonate 2.1 mg, dextrose 0.92 mg, glutathione disulfide (oxidized glutathione) 0.184 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection. The reconstituted product has a pH of approximately 7.4. Osmolality is approximately 305 mOsm.</Description>
</NDC>
<NDC>
<NDCCode>0065-0800-94</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (0065-0800-94) * 480 mL in 1 BAG * 20 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>00065-0800-94</NDC11Code>
<ProductNDC>0065-0800</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bss Plus</ProprietaryName>
<NonProprietaryName>Balanced Salt Solution Enriched With Bicarbonate, Dextrose, And Glutathione</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20130620</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018469</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BSS PLUS solution is indicated for use as an intraocular irrigating solution during intraocular surgical procedures involving perfusion of the eye.</IndicationAndUsage>
<Description>BSS PLUS® is a sterile intraocular irrigating solution for use during all intraocular surgical procedures, including those requiring a relatively long intraocular perfusion time (e.g., pars plana vitrectomy, phacoemulsification, extra capsular cataract extraction/lens aspiration, anterior segment reconstruction, etc.). The solution does not contain a preservative and should be prepared just prior to use in surgery.Part I: Part I is a sterile 480 mL solution in a 500 mL single-dose bag to which the Part II concentrate is added. Each mL of Part I contains: sodium chloride 7.44 mg, potassium chloride 0.395 mg, dibasic sodium phosphate 0.433 mg, sodium bicarbonate 2.19 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection.Part II: Part II is a sterile concentrate in a 20 mL single-dose vial for addition to Part I. Each mL of Part II contains: calcium chloride dihydrate 3.85 mg, magnesium chloride hexahydrate 5 mg, dextrose 23 mg, glutathione disulfide (oxidized glutathione) 4.6 mg, in water for injection.After addition of BSS PLUS solution Part II to the Part I bag, each mL of the reconstituted product contains: sodium chloride 7.14 mg, potassium chloride 0.38 mg, calcium chloride dihydrate 0.154 mg, magnesium chloride hexahydrate 0.2 mg, dibasic sodium phosphate 0.42 mg, sodium bicarbonate 2.1 mg, dextrose 0.92 mg, glutathione disulfide (oxidized glutathione) 0.184 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection.The reconstituted product has a pH of approximately 7.4. Osmolality is approximately 305 mOsm.</Description>
</NDC>
<NDC>
<NDCCode>12784-433-59</NDCCode>
<PackageDescription>59 kg in 1 DRUM (12784-433-59) </PackageDescription>
<NDC11Code>12784-0433-59</NDC11Code>
<ProductNDC>12784-433</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Aluminum Hydroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<StartMarketingDate>20200123</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>SPI PHARMA</LabelerName>
<SubstanceName>ALUMINUM HYDROXIDE</SubstanceName>
<StrengthNumber>76</StrengthNumber>
<StrengthUnit>kg/100kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>23-JAN-20</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>14335-433-01</NDCCode>
<PackageDescription>12 kg in 1 DRUM (14335-433-01) </PackageDescription>
<NDC11Code>14335-0433-01</NDC11Code>
<ProductNDC>14335-433</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Apremilast</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20230815</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Hainan Poly Pharm. Co., Ltd.</LabelerName>
<SubstanceName>APREMILAST</SubstanceName>
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<IndicationAndUsage>Brexpiprazole tablets are indicated for: 1 Adjunctive treatment of major depressive disorder (MDD) in adults., 2 Treatment of schizophrenia in adults.</IndicationAndUsage>
<Description>Brexpiprazole, an atypical antipsychotic, is available as brexpiprazole tablets. Brexpiprazole is 7-{4-[4-(1- Benzothiophen-4-yl)piperazin-1-yl]butoxy}quinolin-2(1H)-one. The molecular formula is C25H27N3O2S and its molecular weight is 433.57. The chemical structure is. Brexpiprazole tablets are for oral administration and are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths. Inactive ingredients include microcrystalline cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, talc, propylene glycol, polyethylene glycol. Colorants includes titanium dioxide, iron oxide red (0.25 mg and 3 mg), FD&C Yellow #6 (0.5 mg), iron oxide yellow (1 mg, 2 mg and 3 mg), FD&C Blue #2 (2 mg).</Description>
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<IndicationAndUsage>Brexpiprazole tablets are indicated for: 1 Adjunctive treatment of major depressive disorder (MDD) in adults., 2 Treatment of schizophrenia in adults.</IndicationAndUsage>
<Description>Brexpiprazole, an atypical antipsychotic, is available as brexpiprazole tablets. Brexpiprazole is 7-{4-[4-(1- Benzothiophen-4-yl)piperazin-1-yl]butoxy}quinolin-2(1H)-one. The molecular formula is C25H27N3O2S and its molecular weight is 433.57. The chemical structure is. Brexpiprazole tablets are for oral administration and are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths. Inactive ingredients include microcrystalline cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, talc, propylene glycol, polyethylene glycol. Colorants includes titanium dioxide, iron oxide red (0.25 mg and 3 mg), FD&C Yellow #6 (0.5 mg), iron oxide yellow (1 mg, 2 mg and 3 mg), FD&C Blue #2 (2 mg).</Description>
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<IndicationAndUsage>Brexpiprazole tablets are indicated for: 1 Adjunctive treatment of major depressive disorder (MDD) in adults., 2 Treatment of schizophrenia in adults.</IndicationAndUsage>
<Description>Brexpiprazole, an atypical antipsychotic, is available as brexpiprazole tablets. Brexpiprazole is 7-{4-[4-(1- Benzothiophen-4-yl)piperazin-1-yl]butoxy}quinolin-2(1H)-one. The molecular formula is C25H27N3O2S and its molecular weight is 433.57. The chemical structure is. Brexpiprazole tablets are for oral administration and are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths. Inactive ingredients include microcrystalline cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, talc, propylene glycol, polyethylene glycol. Colorants includes titanium dioxide, iron oxide red (0.25 mg and 3 mg), FD&C Yellow #6 (0.5 mg), iron oxide yellow (1 mg, 2 mg and 3 mg), FD&C Blue #2 (2 mg).</Description>
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<IndicationAndUsage>Brexpiprazole tablets are indicated for: 1 Adjunctive treatment of major depressive disorder (MDD) in adults., 2 Treatment of schizophrenia in adults.</IndicationAndUsage>
<Description>Brexpiprazole, an atypical antipsychotic, is available as brexpiprazole tablets. Brexpiprazole is 7-{4-[4-(1- Benzothiophen-4-yl)piperazin-1-yl]butoxy}quinolin-2(1H)-one. The molecular formula is C25H27N3O2S and its molecular weight is 433.57. The chemical structure is. Brexpiprazole tablets are for oral administration and are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths. Inactive ingredients include microcrystalline cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, talc, propylene glycol, polyethylene glycol. Colorants includes titanium dioxide, iron oxide red (0.25 mg and 3 mg), FD&C Yellow #6 (0.5 mg), iron oxide yellow (1 mg, 2 mg and 3 mg), FD&C Blue #2 (2 mg).</Description>
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<IndicationAndUsage>Brexpiprazole tablets are indicated for: 1 Adjunctive treatment of major depressive disorder (MDD) in adults., 2 Treatment of schizophrenia in adults.</IndicationAndUsage>
<Description>Brexpiprazole, an atypical antipsychotic, is available as brexpiprazole tablets. Brexpiprazole is 7-{4-[4-(1- Benzothiophen-4-yl)piperazin-1-yl]butoxy}quinolin-2(1H)-one. The molecular formula is C25H27N3O2S and its molecular weight is 433.57. The chemical structure is. Brexpiprazole tablets are for oral administration and are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths. Inactive ingredients include microcrystalline cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, talc, propylene glycol, polyethylene glycol. Colorants includes titanium dioxide, iron oxide red (0.25 mg and 3 mg), FD&C Yellow #6 (0.5 mg), iron oxide yellow (1 mg, 2 mg and 3 mg), FD&C Blue #2 (2 mg).</Description>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Brexpiprazole tablets are indicated for: 1 Adjunctive treatment of major depressive disorder (MDD) in adults., 2 Treatment of schizophrenia in adults.</IndicationAndUsage>
<Description>Brexpiprazole, an atypical antipsychotic, is available as brexpiprazole tablets. Brexpiprazole is 7-{4-[4-(1- Benzothiophen-4-yl)piperazin-1-yl]butoxy}quinolin-2(1H)-one. The molecular formula is C25H27N3O2S and its molecular weight is 433.57. The chemical structure is. Brexpiprazole tablets are for oral administration and are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths. Inactive ingredients include microcrystalline cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, talc, propylene glycol, polyethylene glycol. Colorants includes titanium dioxide, iron oxide red (0.25 mg and 3 mg), FD&C Yellow #6 (0.5 mg), iron oxide yellow (1 mg, 2 mg and 3 mg), FD&C Blue #2 (2 mg).</Description>
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<LabelerName>Dr. Reddys Laboratories Limited</LabelerName>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<IndicationAndUsage>Donepezil hydrochloride tablets are indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.</IndicationAndUsage>
<Description>Donepezil hydrochloride monohydrate USP is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride monohydrate USP is commonly referred to in the pharmacological literature as E2020. It has an molecular formula of C24H29NO3HCl.H2O and a molecular weight of 433.95. Donepezil hydrochloride monohydrate USP is a off-white to white crystalline powder and is soluble in chloroform, water and in glacial aceticacid, slightly soluble in alcohol and acetonitrile, practically insoluble in ethyl acetate and n-Hexane. Donepezil hydrochloride tablets, USP are available for oral administration in film-coated tablets containing 23 mg of donepezil hydrochloride monohydrate USP. Inactive ingredients are hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate and methacrylic acid copolymer. The film coating includes iron oxide red, iron oxide yellow and Opadry OY-58900 White contains hypromellose, polyethylene glycol and titanium dioxide.</Description>
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<RouteName>ORAL</RouteName>
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<IndicationAndUsage>Donepezil hydrochloride tablets are indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.</IndicationAndUsage>
<Description>Donepezil hydrochloride monohydrate USP is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride monohydrate USP is commonly referred to in the pharmacological literature as E2020. It has an molecular formula of C24H29NO3HCl.H2O and a molecular weight of 433.95. Donepezil hydrochloride monohydrate USP is a off-white to white crystalline powder and is soluble in chloroform, water and in glacial aceticacid, slightly soluble in alcohol and acetonitrile, practically insoluble in ethyl acetate and n-Hexane. Donepezil hydrochloride tablets, USP are available for oral administration in film-coated tablets containing 23 mg of donepezil hydrochloride monohydrate USP. Inactive ingredients are hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate and methacrylic acid copolymer. The film coating includes iron oxide red, iron oxide yellow and Opadry OY-58900 White contains hypromellose, polyethylene glycol and titanium dioxide.</Description>
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<LabelerName>Dr. Reddys Laboratories Limited</LabelerName>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Donepezil hydrochloride tablets are indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.</IndicationAndUsage>
<Description>Donepezil hydrochloride monohydrate USP is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride monohydrate. Donepezil hydrochloride monohydrate USP is commonly referred to in the pharmacological literature as E2020. It has an molecular formula of C24H29NO3HCl.H2O and a molecular weight of 433.95. Donepezil hydrochloride monohydrate USP is a off-white to white crystalline powder and is soluble in chloroform, water and in glacial aceticacid, slightly soluble in alcohol and acetonitrile, practically insoluble in ethyl acetate and n-Hexane. Donepezil hydrochloride tablets, USP are available for oral administration in film-coated tablets containing 23 mg of donepezil hydrochloride monohydrate USP. Inactive ingredients are hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate and methacrylic acid copolymer. The film coating includes iron oxide red, iron oxide yellow and Opadry OY-58900 White contains hypromellose, polyethylene glycol and titanium dioxide.</Description>
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<ApplicationNumber>ANDA202723</ApplicationNumber>
<LabelerName>Dr. Reddys Laboratories Limited</LabelerName>
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<StrengthNumber>23</StrengthNumber>
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<Status>Active</Status>
<LastUpdate>2025-08-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Donepezil hydrochloride tablets are indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.</IndicationAndUsage>
<Description>Donepezil hydrochloride monohydrate USP is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride monohydrate. Donepezil hydrochloride monohydrate USP is commonly referred to in the pharmacological literature as E2020. It has an molecular formula of C24H29NO3HCl.H2O and a molecular weight of 433.95. Donepezil hydrochloride monohydrate USP is a off-white to white crystalline powder and is soluble in chloroform, water and in glacial aceticacid, slightly soluble in alcohol and acetonitrile, practically insoluble in ethyl acetate and n-Hexane. Donepezil hydrochloride tablets, USP are available for oral administration in film-coated tablets containing 23 mg of donepezil hydrochloride monohydrate USP. Inactive ingredients are hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate and methacrylic acid copolymer. The film coating includes iron oxide red, iron oxide yellow and Opadry OY-58900 White contains hypromellose, polyethylene glycol and titanium dioxide.</Description>
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<NDC>
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<PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-438-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-438-11) </PackageDescription>
<NDC11Code>60687-0438-01</NDC11Code>
<ProductNDC>60687-438</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mycophenolate Mofetil</ProprietaryName>
<NonProprietaryName>Mycophenolate Mofetil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090456</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>MYCOPHENOLATE MOFETIL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimetabolite Immunosuppressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.</IndicationAndUsage>
<Description>Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C 23H 31NO 7, a molecular weight of 433.50, and the following structural formula:. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. Mycophenolate mofetil is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of MMF. Inactive ingredients in mycophenolate mofetil capsules, USP 250 mg include croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone (K-30). The capsule shells contain FD&C red # 3, gelatin, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. Inactive ingredients in mycophenolate mofetil tablets, USP 500 mg include croscarmellose sodium, magnesium stearate (Vegetable), microcrystalline cellulose, opadry brown, povidone [K-30]. The opadry brown contains FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, hypromellose, iron oxide red, polyethylene glycol and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68382-096-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (68382-096-01) </PackageDescription>
<NDC11Code>68382-0096-01</NDC11Code>
<ProductNDC>68382-096</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxychloroquine Sulfate</ProprietaryName>
<NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040657</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>HYDROXYCHLOROQUINE SULFATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC], Antirheumatic Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydroxychloroquine sulfate tablets is an antimalarial and antirheumatic indicated for the: 1 Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivaxin adult and pediatric patients. (1.1), 2 Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1), 3 Treatment of rheumatoid arthritis in adults. (1.2), 4 Treatment of systemic lupus erythematosus in adults. (1.3), 5 Treatment of chronic discoid lupus erythematosus in adults. (1.4).</IndicationAndUsage>
<Description>Hydroxychloroquine sulfate tablet, USP is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4-quinolyl) amino]pentyl] ethylamino] ethanol sulfate (1:1) with the molecular formula C18H26ClN3OH2SO4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is. Hydroxychloroquine sulfate is a white or practically white, crystalline powder, freely soluble in water; practically insoluble in alcohol, chloroform, and in ether. Each hydroxychloroquine sulfate tablet intended for oral administration contains 200 mg of hydroxychloroquine sulfate, USP equivalent to 155 mg base. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate dihydrate, magnesium stearate, pregelatinized starch, polyethylene glycol, polyvinyl alcohol, starch, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68382-096-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (68382-096-05) </PackageDescription>
<NDC11Code>68382-0096-05</NDC11Code>
<ProductNDC>68382-096</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxychloroquine Sulfate</ProprietaryName>
<NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040657</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>HYDROXYCHLOROQUINE SULFATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC], Antirheumatic Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydroxychloroquine sulfate tablets is an antimalarial and antirheumatic indicated for the: 1 Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivaxin adult and pediatric patients. (1.1), 2 Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1), 3 Treatment of rheumatoid arthritis in adults. (1.2), 4 Treatment of systemic lupus erythematosus in adults. (1.3), 5 Treatment of chronic discoid lupus erythematosus in adults. (1.4).</IndicationAndUsage>
<Description>Hydroxychloroquine sulfate tablet, USP is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4-quinolyl) amino]pentyl] ethylamino] ethanol sulfate (1:1) with the molecular formula C18H26ClN3OH2SO4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is. Hydroxychloroquine sulfate is a white or practically white, crystalline powder, freely soluble in water; practically insoluble in alcohol, chloroform, and in ether. Each hydroxychloroquine sulfate tablet intended for oral administration contains 200 mg of hydroxychloroquine sulfate, USP equivalent to 155 mg base. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate dihydrate, magnesium stearate, pregelatinized starch, polyethylene glycol, polyvinyl alcohol, starch, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68382-096-77</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (68382-096-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68382-096-30) </PackageDescription>
<NDC11Code>68382-0096-77</NDC11Code>
<ProductNDC>68382-096</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxychloroquine Sulfate</ProprietaryName>
<NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040657</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>HYDROXYCHLOROQUINE SULFATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC], Antirheumatic Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydroxychloroquine sulfate tablets is an antimalarial and antirheumatic indicated for the: 1 Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivaxin adult and pediatric patients. (1.1), 2 Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1), 3 Treatment of rheumatoid arthritis in adults. (1.2), 4 Treatment of systemic lupus erythematosus in adults. (1.3), 5 Treatment of chronic discoid lupus erythematosus in adults. (1.4).</IndicationAndUsage>
<Description>Hydroxychloroquine sulfate tablet, USP is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4-quinolyl) amino]pentyl] ethylamino] ethanol sulfate (1:1) with the molecular formula C18H26ClN3OH2SO4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is. Hydroxychloroquine sulfate is a white or practically white, crystalline powder, freely soluble in water; practically insoluble in alcohol, chloroform, and in ether. Each hydroxychloroquine sulfate tablet intended for oral administration contains 200 mg of hydroxychloroquine sulfate, USP equivalent to 155 mg base. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate dihydrate, magnesium stearate, pregelatinized starch, polyethylene glycol, polyvinyl alcohol, starch, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>69842-433-05</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (69842-433-05) * 1 CONTAINER in 1 CARTON (59779-190-03) > 24 LOZENGE in 1 CONTAINER * 2 CONTAINER in 1 CARTON (59779-873-04) > 24 LOZENGE in 1 CONTAINER</PackageDescription>
<NDC11Code>69842-0433-05</NDC11Code>
<ProductNDC>69842-433</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180409</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090711</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2021-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70518-2835-0</NDCCode>
<PackageDescription>100 POUCH in 1 BOX (70518-2835-0) / 1 CAPSULE in 1 POUCH (70518-2835-1) </PackageDescription>
<NDC11Code>70518-2835-00</NDC11Code>
<ProductNDC>70518-2835</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mycophenolate Mofetil</ProprietaryName>
<NonProprietaryName>Mycophenolate Mofetil</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200818</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090253</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>MYCOPHENOLATE MOFETIL</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimetabolite Immunosuppressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)] , heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.</IndicationAndUsage>
<Description>Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1, 3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C 23H 31NO 7, a molecular weight of 433.50, and the following structural formula:. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. Mycophenolate mofetil is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of MMF. Inactive ingredients in mycophenolate mofetil 250 mg capsules include croscarmellose sodium, magnesium stearate, povidone (K-90) microcrystalline cellulose, hydroxy propyl cellulose and talc. The capsule shells contain FD&C blue #2, gelatin, red iron oxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. The imprinting ink contains shellac, iron oxide black and potassium hydroxide. Inactive ingredients in mycophenolate mofetil 500 mg tablets include iron oxide black, croscarmellose sodium, FD&C blue #2 aluminum Lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone (K-90), iron oxide red, talc, and titanium dioxide. Mycophenolate Mofetil Tablets meets USP Dissolution Test 3 and Mycophenolate Mofetil Capsules meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>71335-2933-1</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (71335-2933-1) </PackageDescription>
<NDC11Code>71335-2933-01</NDC11Code>
<ProductNDC>71335-2933</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluvastatin</ProprietaryName>
<NonProprietaryName>Fluvastatin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120705</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078407</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>FLUVASTATIN SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251021</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other non-pharmacologic measures alone has been inadequate.</IndicationAndUsage>
<Description>Fluvastatin sodium, USP is a water-soluble cholesterol lowering agent which acts through the inhibition of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase. Fluvastatin sodium, USP is [R*,S*-(E)]-(±)-7-[3-(4-fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]-3,5-dihydroxy-6-heptenoic acid, monosodium salt. Its structural formula is. C24H25FNNaO4 M.W. 433.45. This molecular entity is the first entirely synthetic HMG-CoA reductase inhibitor, and is in part structurally distinct from the fungal derivatives of this therapeutic class. Fluvastatin sodium, USP (hydrated form) is a white to pale yellow, brownish-pale yellow, or reddish-pale yellow, hygroscopic powder soluble in water, ethanol, and methanol. Fluvastatin Capsules, USP contain fluvastatin sodium, USP (hydrated form), equivalent to 20 mg or 40 mg of fluvastatin, for oral administration. Active Ingredient: fluvastatin sodium, USP (hydrated form). Inactive Ingredients: ammonium hydroxide, black iron oxide, colloidal silicon dioxide, crospovidone, gelatin, lactose monohydrate, magnesium stearate, propylene glycol, red iron oxide, shellac, titanium dioxide, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>72189-433-09</NDCCode>
<PackageDescription>9 TABLET, FILM COATED in 1 BOTTLE (72189-433-09) </PackageDescription>
<NDC11Code>72189-0433-09</NDC11Code>
<ProductNDC>72189-433</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sumatriptan Succinate</ProprietaryName>
<NonProprietaryName>Sumatriptan Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230313</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078295</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sumatriptan succinate tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use:. Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan succinate tablets, reconsider the diagnosis of migraine before sumatriptan succinate tablets are administered to treat any subsequent attacks. Sumatriptan succinate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of sumatriptan succinate tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Sumatriptan succinate tablets contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure. [chemical-structure]. The molecular formula is C14H21N3O2S·C4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan succinate tablet for oral administration contains 35 mg, 70 mg, or 140 mg of sumatriptan succinate, USP equivalent to 25 mg, 50 mg, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C Red # 27 aluminum lake (100 mg only), dibasic calcium phosphate, hypromellose, iron oxide red (100 mg only), magnesium stearate, microcrystalline cellulose, polyethylene glycol (25 mg & 50 mg only), polysorbate 80 (25 mg & 50 mg only) propylene glycol (100 mg only), talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>17312-001-11</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 PACKAGE (17312-001-11) > 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>17312-0001-11</NDC11Code>
<ProductNDC>17312-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ring Relief</ProprietaryName>
<NonProprietaryName>Arnica Montana, Calcium Sulfide, Hypericum Perforatum, Lycopodium Clavatum Spore, Thiosinaminum, Mercurius Solubilis, Salicylic Acid, Silicon Dioxide, Allylthiourea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>AURICULAR (OTIC)</RouteName>
<StartMarketingDate>20060601</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>TRP Company</LabelerName>
<SubstanceName>ARNICA MONTANA; CALCIUM SULFIDE; HYPERICUM PERFORATUM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SALICYLIC ACID; SILICON DIOXIDE; ALLYLTHIOUREA</SubstanceName>
<StrengthNumber>6; 13; 6; 12; 13; 6; 13; 6</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</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-02-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>17312-001-15</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 PACKAGE (17312-001-15) / 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>17312-0001-15</NDC11Code>
<ProductNDC>17312-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ring Relief</ProprietaryName>
<NonProprietaryName>Arnica Montana, Calcium Sulfide, Hypericum Perforatum, Lycopodium Clavatum Spore, Thiosinaminum, Mercurius Solubilis, Salicylic Acid, Silicon Dioxide, Allylthiourea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>AURICULAR (OTIC)</RouteName>
<StartMarketingDate>20060601</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>TRP Company</LabelerName>
<SubstanceName>ARNICA MONTANA; CALCIUM SULFIDE; HYPERICUM PERFORATUM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SALICYLIC ACID; SILICON DIOXIDE; ALLYLTHIOUREA</SubstanceName>
<StrengthNumber>6; 13; 6; 12; 13; 6; 13; 6</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</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses:* According to homeopathic indications, these ingredients temporarily relieve Tinnitus symptoms such as: Ringing Buzzing Roaring Nerve and Noise Sensitivity Pounding Discomfort Wax buildup after serious causes have been ruled out by a physician. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17312-002-11</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 PACKAGE (17312-002-11) > 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>17312-0002-11</NDC11Code>
<ProductNDC>17312-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Blur Relief</ProprietaryName>
<NonProprietaryName>Jacobaea Maritima, Calcium Fluoride, Conium Maculatum Flowering Top, Euphrasia Stricta, Gelsemium Sempervirens Root, Sodium Chloride, Ruta Graveolens Flowering Top</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>INTRAOCULAR</RouteName>
<StartMarketingDate>20060601</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>TRP Company</LabelerName>
<SubstanceName>CALCIUM FLUORIDE; CONIUM MACULATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; JACOBAEA MARITIMA; RUTA GRAVEOLENS FLOWERING TOP; SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>13; 6; 6; 6; 5; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses:*. According to homeopathic indications these ingredients provide temporary relief from symptoms such as: Blurry Vision Dry, Red & Tired Eyes Poor Night Vision (Glare) Difficulty reading after serious causes have been ruled out by a physician. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17312-003-12</NDCCode>
<PackageDescription>1 BOTTLE in 1 PACKAGE (17312-003-12) > 60 TABLET, MULTILAYER in 1 BOTTLE</PackageDescription>
<NDC11Code>17312-0003-12</NDC11Code>
<ProductNDC>17312-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ring Relief</ProprietaryName>
<NonProprietaryName>Potassium Sulfate, Salicylic Acid, Silicon Dioxide, Calcium Sulfate Anhydrous, Quinine Sulfate, Allylthiourea</NonProprietaryName>
<DosageFormName>TABLET, MULTILAYER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060601</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>TRP Company</LabelerName>
<SubstanceName>POTASSIUM SULFATE; SALICYLIC ACID; SILICON DIOXIDE; CALCIUM SULFATE ANHYDROUS; QUININE SULFATE; ALLYLTHIOUREA; CITRUS BIOFLAVONOIDS; GINKGO; THIAMINE; RIBOFLAVIN; NIACINAMIDE; PANTOTHENIC ACID; PYRIDOXINE; CYANOCOBALAMIN; BIOTIN; FOLIC ACID; INOSITOL; ZINC PICOLINATE; ASCORBIC ACID</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 12; 6; 300; 30; .5; .5; 10; 2.5; .5; 200; 100; 200; 37.5; 7.5; 150</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>According to homeopathic indications these ingredients provide temporary relief from symptoms of Tinnitus such as: - Ringing - Buzzing - Noises in ears - Pain and Discomfort.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17312-004-12</NDCCode>
<PackageDescription>1 BOTTLE in 1 PACKAGE (17312-004-12) > 60 TABLET, MULTILAYER in 1 BOTTLE</PackageDescription>
<NDC11Code>17312-0004-12</NDC11Code>
<ProductNDC>17312-004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Temporary Fibromyalgia Pain And Discomfort Relief</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Atropa Belladonna, Causticum, Magnesium Phosphate, Dibasic, Strychnos Nux-vomica Seed, Toxicodendron Pubescens Leaf</NonProprietaryName>
<DosageFormName>TABLET, MULTILAYER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>TRP Company</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ATROPA BELLADONNA; CAUSTICUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; MAGNESIUM ASCORBATE; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE; MAGNESIUM ASCORBATE; MAGNESIUM OXIDE; SELENIUM; SEDUM ROSEUM ROOT</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6; 200; 1; 1; 20; 1; 400; 400; 200; 5; 75; 75; 100; 200</StrengthNumber>
<StrengthUnit>[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>According to homeopathic indications these ingredients provide temporary relief from symptoms of Fibromyalgia such as: - Muscle Pain - Fatigue - Nerve/Soft Tissue Pain - Headache - Multiple Tender Points.</IndicationAndUsage>
</NDC>
</NDCList>