{
"NDC": [
{
"NDCCode": "66096-527-09",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (66096-527-09) ",
"NDC11Code": "66096-0527-09",
"ProductNDC": "66096-527",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ohm Sinus Nasal",
"NonProprietaryName": "Aralia Rac, Euphorbium, Galphimia, Hepar Sulph Calc, Histaminum, Hydrastis, Kali Bic, Kali Iod, Luffa, Pulsatilla, Teucrium Mar.",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20170123",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "ARALIA RACEMOSA ROOT; EUPHORBIA RESINIFERA RESIN; GALPHIMIA GLAUCA FLOWERING TOP; CALCIUM SULFIDE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; POTASSIUM DICHROMATE; POTASSIUM IODIDE; LUFFA OPERCULATA FRUIT; ANEMONE PULSATILLA; TEUCRIUM MARUM",
"StrengthNumber": "6; 6; 6; 12; 12; 12; 12; 4; 6; 6; 6",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170123",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves symptoms associated with allergy and sinus.**. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica."
},
{
"NDCCode": "66096-746-09",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (66096-746-09) ",
"NDC11Code": "66096-0746-09",
"ProductNDC": "66096-746",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Seagate Olive Leaf",
"NonProprietaryName": "Baptisia Tinctoria (wild Indigo)",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20190121",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "BAPTISIA TINCTORIA ROOT",
"StrengthNumber": "4",
"StrengthUnit": "[hp_X]/30mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190121",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. A homeopathic remedy for the temporary relief of colds and sinus irrations."
},
{
"NDCCode": "43547-527-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (43547-527-09) ",
"NDC11Code": "43547-0527-09",
"ProductNDC": "43547-527",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nebivolol",
"NonProprietaryName": "Nebivolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212682",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "NEBIVOLOL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220214",
"SamplePackage": "N",
"IndicationAndUsage": "Nebivolol is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).",
"Description": "The chemical name for the active ingredient in nebivolol tablets (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. Nebivolol tablets for oral administration contain nebivolol hydrochloride equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, pregelatinized starch, sodium lauryl sulfate, D&C Red No. 27 Aluminum Lake (10 mg), FD&C Blue No. 2 Aluminum Lake (2.5 mg and 20 mg), and FD&C Yellow No. 6 Aluminum Lake (5 mg)."
},
{
"NDCCode": "49348-527-09",
"PackageDescription": "2 BOTTLE in 1 CARTON (49348-527-09) > 133 mL in 1 BOTTLE",
"NDC11Code": "49348-0527-09",
"ProductNDC": "49348-527",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunmark Enema",
"NonProprietaryName": "Saline",
"DosageFormName": "ENEMA",
"RouteName": "RECTAL",
"StartMarketingDate": "20091118",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "McKesson",
"SubstanceName": "SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC",
"StrengthNumber": "7; 19",
"StrengthUnit": "g/118mL; g/118mL",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "68180-527-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (68180-527-09) ",
"NDC11Code": "68180-0527-09",
"ProductNDC": "68180-527",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202782",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "23",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151221",
"SamplePackage": "N",
"IndicationAndUsage": "Donepezil hydrochloride tablet is an acetylcholinesterase inhibitor 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 (1).",
"Description": "Donepezil hydrochloride 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 is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. Donepezil Hydrochloride Tablets USP are available for oral administration in film-coated tablets containing 23 mg of donepezil hydrochloride. Inactive ingredients in 23 mg tablets include colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, sodium starch glycolate. The film coating includes hypromellose, iron oxide red, polyethylene glycol, talc and titanium dioxide. Meets USP Dissolution Test 3."
},
{
"NDCCode": "71919-527-09",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (71919-527-09) ",
"NDC11Code": "71919-0527-09",
"ProductNDC": "71919-527",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pertussinum",
"NonProprietaryName": "Human Sputum, Bordetella Pertussis Infected",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20090204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20090204",
"SamplePackage": "N"
},
{
"NDCCode": "66096-158-05",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (66096-158-05)",
"NDC11Code": "66096-0158-05",
"ProductNDC": "66096-158",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"NonProprietaryName": "Allium Cepa, Apis Mellifica, Aralia Racemosa, Blatta Orientalis, Euphrasia Officinalis, Galphimia Glauca, Hedera Helix, Luffa Operculata, Okoubaka, Sabadilla.",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20150417",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "ONION; APIS MELLIFERA; ARALIA RACEMOSA ROOT; BLATTA ORIENTALIS; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HEDERA HELIX FLOWERING TWIG; LUFFA OPERCULATA FRUIT; OKOUBAKA AUBREVILLEI BARK; SCHOENOCAULON OFFICINALE SEED",
"StrengthNumber": "5; 5; 5; 5; 5; 5; 5; 5; 5; 5",
"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",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "USES: Temporarily relieves respiratory symptoms caused by common allergens."
},
{
"NDCCode": "66096-678-02",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (66096-678-02)",
"NDC11Code": "66096-0678-02",
"ProductNDC": "66096-678",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rejuvenate 2000 Maximum Strength Formula For Men",
"NonProprietaryName": "Rsomatotropin, Rigf-i, Rigf-ii, Rna, Dna,glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Orchitinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met.",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20130701",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "SOMATROPIN; DALOTUZUMAB; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; SUS SCROFA PLACENTA; SUS SCROFA TESTICLE; ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; COBALT; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; ZINC",
"StrengthNumber": "6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "USES: Temporarily relieves symptoms of low energy and immune system imbalance."
},
{
"NDCCode": "66096-678-12",
"PackageDescription": "15 mL in 1 BOTTLE, SPRAY (66096-678-12)",
"NDC11Code": "66096-0678-12",
"ProductNDC": "66096-678",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rejuvenate 2000 Maximum Strength Formula For Men",
"NonProprietaryName": "Rsomatotropin, Rigf-i, Rigf-ii, Rna, Dna,glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Orchitinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met.",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20130701",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "SOMATROPIN; DALOTUZUMAB; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; SUS SCROFA PLACENTA; SUS SCROFA TESTICLE; ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; COBALT; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; ZINC",
"StrengthNumber": "6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "USES: Temporarily relieves symptoms of low energy and immune system imbalance."
},
{
"NDCCode": "66096-682-02",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (66096-682-02)",
"NDC11Code": "66096-0682-02",
"ProductNDC": "66096-682",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rejuvenate 2000 Maximum Strength Formula For Women",
"NonProprietaryName": "Rsomatotropin, Rigf-i, Rigf-ii, Rna, Dna,glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Oophorinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met.",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20130701",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "SOMATROPIN; DALOTUZUMAB; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; SUS SCROFA PLACENTA; SUS SCROFA OVARY; ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; COBALT; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; ZINC",
"StrengthNumber": "6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "USES: Temporarily relieves symptoms of low energy and immune system imbalance."
},
{
"NDCCode": "66096-682-12",
"PackageDescription": "15 mL in 1 BOTTLE, SPRAY (66096-682-12)",
"NDC11Code": "66096-0682-12",
"ProductNDC": "66096-682",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rejuvenate 2000 Maximum Strength Formula For Women",
"NonProprietaryName": "Rsomatotropin, Rigf-i, Rigf-ii, Rna, Dna,glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Oophorinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met.",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20130701",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "SOMATROPIN; DALOTUZUMAB; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; SUS SCROFA PLACENTA; SUS SCROFA OVARY; ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; COBALT; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; ZINC",
"StrengthNumber": "6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "USES: Temporarily relieves symptoms of low energy and immune system imbalance."
},
{
"NDCCode": "66096-683-02",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (66096-683-02)",
"NDC11Code": "66096-0683-02",
"ProductNDC": "66096-683",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rejuvenate 2000 Power Up Formula For Men",
"NonProprietaryName": "Rsomatotropin, Rigf-i, Rigf-ii, Rna, Dna,glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Orchitinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met.",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20130701",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "SOMATROPIN; DALOTUZUMAB; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; SUS SCROFA PLACENTA; SUS SCROFA TESTICLE; ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; COBALT; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; ZINC",
"StrengthNumber": "6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "USES: Temporarily relieves symptoms of low energy and immune system imbalance."
},
{
"NDCCode": "66096-684-02",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (66096-684-02)",
"NDC11Code": "66096-0684-02",
"ProductNDC": "66096-684",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rejuvenate 2000 Pm Formula For Men",
"NonProprietaryName": "Rsomatotropin, Rigf-i, Rigf-ii, Rna, Dna,glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Orchitinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met.",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20130701",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "SOMATROPIN; DALOTUZUMAB; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; SUS SCROFA PLACENTA; SUS SCROFA TESTICLE; ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; COBALT; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; ZINC",
"StrengthNumber": "6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "USES: Temporarily relieves symptoms of low energy and occasional sleeplessness."
},
{
"NDCCode": "66096-685-02",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (66096-685-02)",
"NDC11Code": "66096-0685-02",
"ProductNDC": "66096-685",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rejuvenate 2000 Pm Formula For Women",
"NonProprietaryName": "Rsomatotropin, Rigf-i, Rigf-ii, Rna, Dna,glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Oophorinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met.",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20130701",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "SOMATROPIN; DALOTUZUMAB; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; SUS SCROFA PLACENTA; SUS SCROFA OVARY; ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; COBALT; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; ZINC",
"StrengthNumber": "6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "USES: Temporarily relieves symptoms of low energy and occasional sleeplessness."
},
{
"NDCCode": "66096-686-02",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (66096-686-02)",
"NDC11Code": "66096-0686-02",
"ProductNDC": "66096-686",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rejuvenate 2000 Athletic Formula For Women",
"NonProprietaryName": "Rsomatotropin, Rigf-i, Rigf-ii, Rna, Dna,glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Oophorinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met.",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20130701",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "SOMATROPIN; DALOTUZUMAB; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; SUS SCROFA PLACENTA; SUS SCROFA OVARY; ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; COBALT; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; ZINC",
"StrengthNumber": "6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "USES: Temporarily relieves symptoms of low energy and immune system imbalance."
},
{
"NDCCode": "66096-687-02",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (66096-687-02)",
"NDC11Code": "66096-0687-02",
"ProductNDC": "66096-687",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rejuvenate 2000 Athletic Formula For Men",
"NonProprietaryName": "Rsomatotropin, Rigf-i, Rigf-ii, Rna, Dna,glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Orchitinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met.",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20130701",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "SOMATROPIN; DALOTUZUMAB; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; SUS SCROFA PLACENTA; SUS SCROFA TESTICLE; ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; COBALT; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; ZINC",
"StrengthNumber": "6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "USES: Temporarily relieves symptoms of low energy and immune system imbalance."
},
{
"NDCCode": "66096-715-02",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (66096-715-02)",
"NDC11Code": "66096-0715-02",
"ProductNDC": "66096-715",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rhus Tox 4x, 8x, 12x",
"NonProprietaryName": "Rhus Toxicodendron.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170306",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "4",
"StrengthUnit": "[hp_X]/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "USES: Temporarily relieves blistering rash.**. ** These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice."
},
{
"NDCCode": "66096-716-02",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (66096-716-02)",
"NDC11Code": "66096-0716-02",
"ProductNDC": "66096-716",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydrate Ii",
"NonProprietaryName": "Berberis Aquifolium, Beta Vulgaris, Boldo, Chelidonium Majus, Hordeum Vulgare, Iris Versicolor, Rosmarinus Officinale, Carduus Marianus, Taraxacum Officinale, Avena Sativa, Eleutherococcus Senticosus, Xanthoxylum Fraxineum, Equisetum Hyemale, Hypericum Perforatum, Ulmus Fulva, Gettysburg Aqua, Glycyrrhiza Glabra, Wildbad Aqua, Carlsbad Aqua, Atp, Hydrogen, Natrum Muriaticum, Oxygen, Silicea, Wiesbaden Aqua.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170314",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "BERBERIS AQUIFOLIUM ROOT BARK; BETA VULGARIS; PEUMUS BOLDUS LEAF; MILK THISTLE; CHELIDONIUM MAJUS; BARLEY; IRIS VERSICOLOR ROOT; ROSMARINUS OFFICINALIS FLOWERING TOP; TARAXACUM OFFICINALE; AVENA SATIVA FLOWERING TOP; ELEUTHERO; ZANTHOXYLUM AMERICANUM BARK; EQUISETUM HYEMALE; HYPERICUM PERFORATUM; ULMUS RUBRA BARK; GLYCYRRHIZA GLABRA; ADENOSINE TRIPHOSPHATE; HYDROGEN; SODIUM CHLORIDE; OXYGEN; SILICON DIOXIDE",
"StrengthNumber": "8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "USES: Temporarily relieves low energy, circulatory disorders, digestive upset, &/or symptoms related to poor cellular hydration.**. **These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice."
},
{
"NDCCode": "0069-0242-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0242-30) ",
"NDC11Code": "00069-0242-30",
"ProductNDC": "0069-0242",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Toviaz",
"NonProprietaryName": "Fesoterodine Fumarate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20081031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022030",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "FESOTERODINE FUMARATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20081031",
"SamplePackage": "N",
"IndicationAndUsage": "Toviaz is indicated for the treatment of: 1 Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. (1.1), 2 Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg. (1.2).",
"Description": "Toviaz contains fesoterodine fumarate and is an extended-release tablet. Fesoterodine is rapidly de-esterified to its active metabolite (R)-2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethyl-phenol, or 5-hydroxymethyl tolterodine, which is a muscarinic receptor antagonist. Chemically, fesoterodine fumarate is designated as isobutyric acid 2-((R)-3-diisopropylammonium-1-phenylpropyl)-4-(hydroxymethyl) phenyl ester hydrogen fumarate. The empirical formula is C30H41NO7 and its molecular weight is 527.66. The structural formula is. The asterisk (*) indicates the chiral carbon. Fesoterodine fumarate is a white to off-white powder, which is freely soluble in water. Each Toviaz extended-release tablet contains either 4 mg or 8 mg of fesoterodine fumarate and the following inactive ingredients: glyceryl behenate, hypromellose, indigo carmine aluminum lake, lactose monohydrate, soya lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and xylitol."
},
{
"NDCCode": "0069-0244-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0244-30) ",
"NDC11Code": "00069-0244-30",
"ProductNDC": "0069-0244",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Toviaz",
"NonProprietaryName": "Fesoterodine Fumarate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20081031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022030",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "FESOTERODINE FUMARATE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20081031",
"SamplePackage": "N",
"IndicationAndUsage": "Toviaz is indicated for the treatment of: 1 Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. (1.1), 2 Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg. (1.2).",
"Description": "Toviaz contains fesoterodine fumarate and is an extended-release tablet. Fesoterodine is rapidly de-esterified to its active metabolite (R)-2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethyl-phenol, or 5-hydroxymethyl tolterodine, which is a muscarinic receptor antagonist. Chemically, fesoterodine fumarate is designated as isobutyric acid 2-((R)-3-diisopropylammonium-1-phenylpropyl)-4-(hydroxymethyl) phenyl ester hydrogen fumarate. The empirical formula is C30H41NO7 and its molecular weight is 527.66. The structural formula is. The asterisk (*) indicates the chiral carbon. Fesoterodine fumarate is a white to off-white powder, which is freely soluble in water. Each Toviaz extended-release tablet contains either 4 mg or 8 mg of fesoterodine fumarate and the following inactive ingredients: glyceryl behenate, hypromellose, indigo carmine aluminum lake, lactose monohydrate, soya lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and xylitol."
},
{
"NDCCode": "0115-1248-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-01) ",
"NDC11Code": "00115-1248-01",
"ProductNDC": "0115-1248",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol Phosphate",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204717",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240101",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 ½ EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac."
},
{
"NDCCode": "0115-1248-03",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-03) ",
"NDC11Code": "00115-1248-03",
"ProductNDC": "0115-1248",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol Phosphate",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204717",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240101",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 ½ EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac."
},
{
"NDCCode": "0115-1248-08",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-08) ",
"NDC11Code": "00115-1248-08",
"ProductNDC": "0115-1248",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol Phosphate",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204717",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240101",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 ½ EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac."
},
{
"NDCCode": "0115-1248-10",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-10) ",
"NDC11Code": "00115-1248-10",
"ProductNDC": "0115-1248",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol Phosphate",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204717",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240101",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 ½ EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac."
},
{
"NDCCode": "0115-1249-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1249-01) ",
"NDC11Code": "00115-1249-01",
"ProductNDC": "0115-1249",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol Phosphate",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204717",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240101",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 ½ EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac."
},
{
"NDCCode": "0115-1249-03",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1249-03) ",
"NDC11Code": "00115-1249-03",
"ProductNDC": "0115-1249",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol Phosphate",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204717",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240101",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 ½ EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac."
},
{
"NDCCode": "0115-1249-08",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1249-08) ",
"NDC11Code": "00115-1249-08",
"ProductNDC": "0115-1249",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol Phosphate",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204717",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240101",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 ½ EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac."
},
{
"NDCCode": "0115-1249-10",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1249-10) ",
"NDC11Code": "00115-1249-10",
"ProductNDC": "0115-1249",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol Phosphate",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204717",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240101",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 ½ EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac."
},
{
"NDCCode": "0115-1250-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1250-01) ",
"NDC11Code": "00115-1250-01",
"ProductNDC": "0115-1250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol Phosphate",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204717",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20240101",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 ½ EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac."
},
{
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"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1250-03) ",
"NDC11Code": "00115-1250-03",
"ProductNDC": "0115-1250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"RouteName": "ORAL",
"StartMarketingDate": "20240101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204717",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
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"StrengthUnit": "mg/1",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 ½ EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac."
}
]
}
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<SubstanceName>ARALIA RACEMOSA ROOT; EUPHORBIA RESINIFERA RESIN; GALPHIMIA GLAUCA FLOWERING TOP; CALCIUM SULFIDE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; POTASSIUM DICHROMATE; POTASSIUM IODIDE; LUFFA OPERCULATA FRUIT; ANEMONE PULSATILLA; TEUCRIUM MARUM</SubstanceName>
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<ProductNDC>66096-746</ProductNDC>
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<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>BAPTISIA TINCTORIA ROOT</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>[hp_X]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. A homeopathic remedy for the temporary relief of colds and sinus irrations.</IndicationAndUsage>
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<PackageDescription>90 TABLET in 1 BOTTLE (43547-527-09) </PackageDescription>
<NDC11Code>43547-0527-09</NDC11Code>
<ProductNDC>43547-527</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nebivolol</ProprietaryName>
<NonProprietaryName>Nebivolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212682</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>NEBIVOLOL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nebivolol is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
<Description>The chemical name for the active ingredient in nebivolol tablets (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. Nebivolol tablets for oral administration contain nebivolol hydrochloride equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, pregelatinized starch, sodium lauryl sulfate, D&C Red No. 27 Aluminum Lake (10 mg), FD&C Blue No. 2 Aluminum Lake (2.5 mg and 20 mg), and FD&C Yellow No. 6 Aluminum Lake (5 mg).</Description>
</NDC>
<NDC>
<NDCCode>49348-527-09</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (49348-527-09) > 133 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>49348-0527-09</NDC11Code>
<ProductNDC>49348-527</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sunmark Enema</ProprietaryName>
<NonProprietaryName>Saline</NonProprietaryName>
<DosageFormName>ENEMA</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20091118</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>McKesson</LabelerName>
<SubstanceName>SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC</SubstanceName>
<StrengthNumber>7; 19</StrengthNumber>
<StrengthUnit>g/118mL; g/118mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>68180-527-09</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (68180-527-09) </PackageDescription>
<NDC11Code>68180-0527-09</NDC11Code>
<ProductNDC>68180-527</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202782</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>23</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Donepezil hydrochloride tablet is an acetylcholinesterase inhibitor 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 (1).</IndicationAndUsage>
<Description>Donepezil hydrochloride 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 is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. Donepezil Hydrochloride Tablets USP are available for oral administration in film-coated tablets containing 23 mg of donepezil hydrochloride. Inactive ingredients in 23 mg tablets include colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, sodium starch glycolate. The film coating includes hypromellose, iron oxide red, polyethylene glycol, talc and titanium dioxide. Meets USP Dissolution Test 3.</Description>
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<ProductNDC>71919-527</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pertussinum</ProprietaryName>
<NonProprietaryName>Human Sputum, Bordetella Pertussis Infected</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20090204</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66096-158-05</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (66096-158-05)</PackageDescription>
<NDC11Code>66096-0158-05</NDC11Code>
<ProductNDC>66096-158</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Relief</ProprietaryName>
<NonProprietaryName>Allium Cepa, Apis Mellifica, Aralia Racemosa, Blatta Orientalis, Euphrasia Officinalis, Galphimia Glauca, Hedera Helix, Luffa Operculata, Okoubaka, Sabadilla.</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150417</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>ONION; APIS MELLIFERA; ARALIA RACEMOSA ROOT; BLATTA ORIENTALIS; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HEDERA HELIX FLOWERING TWIG; LUFFA OPERCULATA FRUIT; OKOUBAKA AUBREVILLEI BARK; SCHOENOCAULON OFFICINALE SEED</SubstanceName>
<StrengthNumber>5; 5; 5; 5; 5; 5; 5; 5; 5; 5</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>USES: Temporarily relieves respiratory symptoms caused by common allergens.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-678-02</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (66096-678-02)</PackageDescription>
<NDC11Code>66096-0678-02</NDC11Code>
<ProductNDC>66096-678</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rejuvenate 2000 Maximum Strength Formula For Men</ProprietaryName>
<NonProprietaryName>Rsomatotropin, Rigf-i, Rigf-ii, Rna, Dna,glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Orchitinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met.</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>SOMATROPIN; DALOTUZUMAB; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; SUS SCROFA PLACENTA; SUS SCROFA TESTICLE; ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; COBALT; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; ZINC</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>USES: Temporarily relieves symptoms of low energy and immune system imbalance.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-678-12</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE, SPRAY (66096-678-12)</PackageDescription>
<NDC11Code>66096-0678-12</NDC11Code>
<ProductNDC>66096-678</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rejuvenate 2000 Maximum Strength Formula For Men</ProprietaryName>
<NonProprietaryName>Rsomatotropin, Rigf-i, Rigf-ii, Rna, Dna,glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Orchitinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met.</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>SOMATROPIN; DALOTUZUMAB; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; SUS SCROFA PLACENTA; SUS SCROFA TESTICLE; ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; COBALT; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; ZINC</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>USES: Temporarily relieves symptoms of low energy and immune system imbalance.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-682-02</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (66096-682-02)</PackageDescription>
<NDC11Code>66096-0682-02</NDC11Code>
<ProductNDC>66096-682</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rejuvenate 2000 Maximum Strength Formula For Women</ProprietaryName>
<NonProprietaryName>Rsomatotropin, Rigf-i, Rigf-ii, Rna, Dna,glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Oophorinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met.</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>SOMATROPIN; DALOTUZUMAB; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; SUS SCROFA PLACENTA; SUS SCROFA OVARY; ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; COBALT; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; ZINC</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>USES: Temporarily relieves symptoms of low energy and immune system imbalance.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-682-12</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE, SPRAY (66096-682-12)</PackageDescription>
<NDC11Code>66096-0682-12</NDC11Code>
<ProductNDC>66096-682</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rejuvenate 2000 Maximum Strength Formula For Women</ProprietaryName>
<NonProprietaryName>Rsomatotropin, Rigf-i, Rigf-ii, Rna, Dna,glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Oophorinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met.</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>SOMATROPIN; DALOTUZUMAB; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; SUS SCROFA PLACENTA; SUS SCROFA OVARY; ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; COBALT; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; ZINC</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>USES: Temporarily relieves symptoms of low energy and immune system imbalance.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-683-02</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (66096-683-02)</PackageDescription>
<NDC11Code>66096-0683-02</NDC11Code>
<ProductNDC>66096-683</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rejuvenate 2000 Power Up Formula For Men</ProprietaryName>
<NonProprietaryName>Rsomatotropin, Rigf-i, Rigf-ii, Rna, Dna,glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Orchitinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met.</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>SOMATROPIN; DALOTUZUMAB; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; SUS SCROFA PLACENTA; SUS SCROFA TESTICLE; ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; COBALT; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; ZINC</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>USES: Temporarily relieves symptoms of low energy and immune system imbalance.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-684-02</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (66096-684-02)</PackageDescription>
<NDC11Code>66096-0684-02</NDC11Code>
<ProductNDC>66096-684</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rejuvenate 2000 Pm Formula For Men</ProprietaryName>
<NonProprietaryName>Rsomatotropin, Rigf-i, Rigf-ii, Rna, Dna,glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Orchitinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met.</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>SOMATROPIN; DALOTUZUMAB; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; SUS SCROFA PLACENTA; SUS SCROFA TESTICLE; ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; COBALT; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; ZINC</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>USES: Temporarily relieves symptoms of low energy and occasional sleeplessness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-685-02</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (66096-685-02)</PackageDescription>
<NDC11Code>66096-0685-02</NDC11Code>
<ProductNDC>66096-685</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rejuvenate 2000 Pm Formula For Women</ProprietaryName>
<NonProprietaryName>Rsomatotropin, Rigf-i, Rigf-ii, Rna, Dna,glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Oophorinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met.</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>SOMATROPIN; DALOTUZUMAB; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; SUS SCROFA PLACENTA; SUS SCROFA OVARY; ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; COBALT; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; ZINC</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>USES: Temporarily relieves symptoms of low energy and occasional sleeplessness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-686-02</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (66096-686-02)</PackageDescription>
<NDC11Code>66096-0686-02</NDC11Code>
<ProductNDC>66096-686</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rejuvenate 2000 Athletic Formula For Women</ProprietaryName>
<NonProprietaryName>Rsomatotropin, Rigf-i, Rigf-ii, Rna, Dna,glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Oophorinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met.</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>SOMATROPIN; DALOTUZUMAB; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; SUS SCROFA PLACENTA; SUS SCROFA OVARY; ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; COBALT; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; ZINC</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>USES: Temporarily relieves symptoms of low energy and immune system imbalance.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-687-02</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (66096-687-02)</PackageDescription>
<NDC11Code>66096-0687-02</NDC11Code>
<ProductNDC>66096-687</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rejuvenate 2000 Athletic Formula For Men</ProprietaryName>
<NonProprietaryName>Rsomatotropin, Rigf-i, Rigf-ii, Rna, Dna,glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Orchitinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met.</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>SOMATROPIN; DALOTUZUMAB; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; SUS SCROFA PLACENTA; SUS SCROFA TESTICLE; ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; COBALT; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; ZINC</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>USES: Temporarily relieves symptoms of low energy and immune system imbalance.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-715-02</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (66096-715-02)</PackageDescription>
<NDC11Code>66096-0715-02</NDC11Code>
<ProductNDC>66096-715</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rhus Tox 4x, 8x, 12x</ProprietaryName>
<NonProprietaryName>Rhus Toxicodendron.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170306</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>[hp_X]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>USES: Temporarily relieves blistering rash.**. ** These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-716-02</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (66096-716-02)</PackageDescription>
<NDC11Code>66096-0716-02</NDC11Code>
<ProductNDC>66096-716</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrate Ii</ProprietaryName>
<NonProprietaryName>Berberis Aquifolium, Beta Vulgaris, Boldo, Chelidonium Majus, Hordeum Vulgare, Iris Versicolor, Rosmarinus Officinale, Carduus Marianus, Taraxacum Officinale, Avena Sativa, Eleutherococcus Senticosus, Xanthoxylum Fraxineum, Equisetum Hyemale, Hypericum Perforatum, Ulmus Fulva, Gettysburg Aqua, Glycyrrhiza Glabra, Wildbad Aqua, Carlsbad Aqua, Atp, Hydrogen, Natrum Muriaticum, Oxygen, Silicea, Wiesbaden Aqua.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170314</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>BERBERIS AQUIFOLIUM ROOT BARK; BETA VULGARIS; PEUMUS BOLDUS LEAF; MILK THISTLE; CHELIDONIUM MAJUS; BARLEY; IRIS VERSICOLOR ROOT; ROSMARINUS OFFICINALIS FLOWERING TOP; TARAXACUM OFFICINALE; AVENA SATIVA FLOWERING TOP; ELEUTHERO; ZANTHOXYLUM AMERICANUM BARK; EQUISETUM HYEMALE; HYPERICUM PERFORATUM; ULMUS RUBRA BARK; GLYCYRRHIZA GLABRA; ADENOSINE TRIPHOSPHATE; HYDROGEN; SODIUM CHLORIDE; OXYGEN; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>USES: Temporarily relieves low energy, circulatory disorders, digestive upset, &/or symptoms related to poor cellular hydration.**. **These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0069-0242-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0242-30) </PackageDescription>
<NDC11Code>00069-0242-30</NDC11Code>
<ProductNDC>0069-0242</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Toviaz</ProprietaryName>
<NonProprietaryName>Fesoterodine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081031</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022030</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>FESOTERODINE FUMARATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Toviaz is indicated for the treatment of: 1 Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. (1.1), 2 Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg. (1.2).</IndicationAndUsage>
<Description>Toviaz contains fesoterodine fumarate and is an extended-release tablet. Fesoterodine is rapidly de-esterified to its active metabolite (R)-2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethyl-phenol, or 5-hydroxymethyl tolterodine, which is a muscarinic receptor antagonist. Chemically, fesoterodine fumarate is designated as isobutyric acid 2-((R)-3-diisopropylammonium-1-phenylpropyl)-4-(hydroxymethyl) phenyl ester hydrogen fumarate. The empirical formula is C30H41NO7 and its molecular weight is 527.66. The structural formula is. The asterisk (*) indicates the chiral carbon. Fesoterodine fumarate is a white to off-white powder, which is freely soluble in water. Each Toviaz extended-release tablet contains either 4 mg or 8 mg of fesoterodine fumarate and the following inactive ingredients: glyceryl behenate, hypromellose, indigo carmine aluminum lake, lactose monohydrate, soya lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and xylitol.</Description>
</NDC>
<NDC>
<NDCCode>0069-0244-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0244-30) </PackageDescription>
<NDC11Code>00069-0244-30</NDC11Code>
<ProductNDC>0069-0244</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Toviaz</ProprietaryName>
<NonProprietaryName>Fesoterodine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081031</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022030</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>FESOTERODINE FUMARATE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Toviaz is indicated for the treatment of: 1 Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. (1.1), 2 Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg. (1.2).</IndicationAndUsage>
<Description>Toviaz contains fesoterodine fumarate and is an extended-release tablet. Fesoterodine is rapidly de-esterified to its active metabolite (R)-2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethyl-phenol, or 5-hydroxymethyl tolterodine, which is a muscarinic receptor antagonist. Chemically, fesoterodine fumarate is designated as isobutyric acid 2-((R)-3-diisopropylammonium-1-phenylpropyl)-4-(hydroxymethyl) phenyl ester hydrogen fumarate. The empirical formula is C30H41NO7 and its molecular weight is 527.66. The structural formula is. The asterisk (*) indicates the chiral carbon. Fesoterodine fumarate is a white to off-white powder, which is freely soluble in water. Each Toviaz extended-release tablet contains either 4 mg or 8 mg of fesoterodine fumarate and the following inactive ingredients: glyceryl behenate, hypromellose, indigo carmine aluminum lake, lactose monohydrate, soya lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and xylitol.</Description>
</NDC>
<NDC>
<NDCCode>0115-1248-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-01) </PackageDescription>
<NDC11Code>00115-1248-01</NDC11Code>
<ProductNDC>0115-1248</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol Phosphate</ProprietaryName>
<NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204717</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
<Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 &frac12; EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac.</Description>
</NDC>
<NDC>
<NDCCode>0115-1248-03</NDCCode>
<PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-03) </PackageDescription>
<NDC11Code>00115-1248-03</NDC11Code>
<ProductNDC>0115-1248</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol Phosphate</ProprietaryName>
<NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204717</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
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<Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 &frac12; EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac.</Description>
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<Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 &frac12; EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac.</Description>
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<Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 &frac12; EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac.</Description>
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<Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 &frac12; EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac.</Description>
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<Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 &frac12; EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac.</Description>
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<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
<Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 &frac12; EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac.</Description>
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