{
"NDC": [
{
"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": "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": "20261231",
"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": "66096-158-05",
"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": "11559-746-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (11559-746-01) > 30 mL in 1 BOTTLE (11559-746-02)",
"NDC11Code": "11559-0746-01",
"ProductNDC": "11559-746",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Renutriv",
"ProprietaryNameSuffix": "Ultimate Radiance Makeup Spf 15",
"NonProprietaryName": "Octinoxate, Titanium Dioxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "ESTEE LAUDER INC",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "2.2; 1.4",
"StrengthUnit": "mL/100mL; mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "21695-746-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (21695-746-30)",
"NDC11Code": "21695-0746-30",
"ProductNDC": "21695-746",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glimepiride",
"NonProprietaryName": "Glimepiride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077091",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "GLIMEPIRIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea [EPC],Sulfonylurea Compounds [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (See DOSAGE AND ADMINISTRATION section).",
"Description": "Glimepiride tablets USP, are an oral blood-glucose-lowering drug of the sulfonylurea class. Glimepiride is a white to yellowish-white, crystalline, odorless to practically odorless powder formulated into tablets of 1 mg, 2 mg, and 4 mg strengths for oral administration. Glimepiride tablets contain the active ingredient glimepiride and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. In addition, glimepiride 1 mg tablets contain ferric oxide red, glimepiride 2 mg tablets contain lake blend green (contains D&C yellow # 10 aluminium lake and FD&C blue #1/ brilliant blue FCF aluminium lake) and glimepiride 4 mg tablets contain lake blend blue (contains D&C yellow # 10 aluminium lake and FD&C blue # 1/ brilliant blue FCF aluminium lake). Chemically, glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1- carboxamido)ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea. The CAS Registry Number is 93479-97-1. The structural formula is. Molecular Formula: C24H34N4O5S. Molecular Weight: 490.62. Glimepiride is practically insoluble in water."
},
{
"NDCCode": "21695-746-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (21695-746-90)",
"NDC11Code": "21695-0746-90",
"ProductNDC": "21695-746",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glimepiride",
"NonProprietaryName": "Glimepiride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077091",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "GLIMEPIRIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea [EPC],Sulfonylurea Compounds [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (See DOSAGE AND ADMINISTRATION section).",
"Description": "Glimepiride tablets USP, are an oral blood-glucose-lowering drug of the sulfonylurea class. Glimepiride is a white to yellowish-white, crystalline, odorless to practically odorless powder formulated into tablets of 1 mg, 2 mg, and 4 mg strengths for oral administration. Glimepiride tablets contain the active ingredient glimepiride and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. In addition, glimepiride 1 mg tablets contain ferric oxide red, glimepiride 2 mg tablets contain lake blend green (contains D&C yellow # 10 aluminium lake and FD&C blue #1/ brilliant blue FCF aluminium lake) and glimepiride 4 mg tablets contain lake blend blue (contains D&C yellow # 10 aluminium lake and FD&C blue # 1/ brilliant blue FCF aluminium lake). Chemically, glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1- carboxamido)ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea. The CAS Registry Number is 93479-97-1. The structural formula is. Molecular Formula: C24H34N4O5S. Molecular Weight: 490.62. Glimepiride is practically insoluble in water."
},
{
"NDCCode": "49527-746-01",
"PackageDescription": "1 JAR in 1 CARTON (49527-746-01) > 18 g in 1 JAR (49527-746-02)",
"NDC11Code": "49527-0746-01",
"ProductNDC": "49527-746",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Superbalanced",
"ProprietaryNameSuffix": "Makeup Spf 15 Mineral Rich Formula",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100401",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "CLINIQUE LABORATORIES INC.",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "6.3",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "51079-746-19",
"PackageDescription": "25 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-746-19) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-746-17)",
"NDC11Code": "51079-0746-19",
"ProductNDC": "51079-746",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19960307",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072838",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-09-25",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "52959-746-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (52959-746-30)",
"NDC11Code": "52959-0746-30",
"ProductNDC": "52959-746",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lyrica",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20041230",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021724",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "LYRICA is indicated for.",
"Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients."
},
{
"NDCCode": "52959-746-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (52959-746-60)",
"NDC11Code": "52959-0746-60",
"ProductNDC": "52959-746",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lyrica",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20041230",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021724",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "LYRICA is indicated for.",
"Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients."
},
{
"NDCCode": "52959-746-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (52959-746-90)",
"NDC11Code": "52959-0746-90",
"ProductNDC": "52959-746",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lyrica",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20041230",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021724",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "LYRICA is indicated for.",
"Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients."
},
{
"NDCCode": "55289-746-10",
"PackageDescription": "10 TABLET in 1 BOTTLE, PLASTIC (55289-746-10) ",
"NDC11Code": "55289-0746-10",
"ProductNDC": "55289-746",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trimethoprim",
"NonProprietaryName": "Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100404",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070049",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "TRIMETHOPRIM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180215",
"SamplePackage": "N"
},
{
"NDCCode": "63868-746-07",
"PackageDescription": "177 mL in 1 BOTTLE, PLASTIC (63868-746-07) ",
"NDC11Code": "63868-0746-07",
"ProductNDC": "63868-746",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus Relief Cold Flu And Sore Throat",
"ProprietaryNameSuffix": "Maximum Strength",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150131",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "QUALITY CHOICE (Chain Drug Marketing Association)",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "650; 20; 400; 10",
"StrengthUnit": "mg/20mL; mg/20mL; mg/20mL; mg/20mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150131",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these common cold and flu symptoms:sinus congestion and pressureminor aches and painsnasal congestioncough due to minor throat and bronchial irritationsore throatheadache. temporarily reduces fever. temporarily promotes nasal and/or sinus drainage. helps loosen phlegm (mucus) amd thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ."
},
{
"NDCCode": "68180-746-06",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (68180-746-06) ",
"NDC11Code": "68180-0746-06",
"ProductNDC": "68180-746",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20201211",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021695",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20201211",
"SamplePackage": "N"
},
{
"NDCCode": "69238-1151-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (69238-1151-3) ",
"NDC11Code": "69238-1151-03",
"ProductNDC": "69238-1151",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vardenafil Hydrochloride",
"NonProprietaryName": "Vardenafil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210738",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "VARDENAFIL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20181031",
"SamplePackage": "N",
"IndicationAndUsage": "Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil hydrochloride is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride, trihydrate and has the following structural formula. Molecular weight - 579.11 g/mol. Molecular formula - C23H32N6O4S.HCl.3H2O. Vardenafil hydrochloride trihydrate is white or slightly brown or yellow powder. It is freely soluble in anhydrous alcohol; slightly soluble in water; practically insoluble in heptane. Each film-coated tablet contains active ingredient 5 mg, 10 mg or 20 mg of vardenafil equivalent to 5.926 mg, 11.852 mg or 23.704 vardenafil hydrochloride trihydrate respectively which is equivalent to 5.373 mg, 10.746 mg or 21.492 mg of vardenafil hydrochloride respectively. Each film-coated tablet contains inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol, microcrystalline cellulose, sodium stearyl fumarate, talc and titanium dioxide."
},
{
"NDCCode": "69238-1152-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (69238-1152-3) ",
"NDC11Code": "69238-1152-03",
"ProductNDC": "69238-1152",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vardenafil Hydrochloride",
"NonProprietaryName": "Vardenafil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210738",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "VARDENAFIL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20181031",
"SamplePackage": "N",
"IndicationAndUsage": "Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil hydrochloride is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride, trihydrate and has the following structural formula. Molecular weight - 579.11 g/mol. Molecular formula - C23H32N6O4S.HCl.3H2O. Vardenafil hydrochloride trihydrate is white or slightly brown or yellow powder. It is freely soluble in anhydrous alcohol; slightly soluble in water; practically insoluble in heptane. Each film-coated tablet contains active ingredient 5 mg, 10 mg or 20 mg of vardenafil equivalent to 5.926 mg, 11.852 mg or 23.704 vardenafil hydrochloride trihydrate respectively which is equivalent to 5.373 mg, 10.746 mg or 21.492 mg of vardenafil hydrochloride respectively. Each film-coated tablet contains inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol, microcrystalline cellulose, sodium stearyl fumarate, talc and titanium dioxide."
},
{
"NDCCode": "69238-1153-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (69238-1153-3) ",
"NDC11Code": "69238-1153-03",
"ProductNDC": "69238-1153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vardenafil Hydrochloride",
"NonProprietaryName": "Vardenafil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210738",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "VARDENAFIL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20181031",
"SamplePackage": "N",
"IndicationAndUsage": "Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil hydrochloride is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride, trihydrate and has the following structural formula. Molecular weight - 579.11 g/mol. Molecular formula - C23H32N6O4S.HCl.3H2O. Vardenafil hydrochloride trihydrate is white or slightly brown or yellow powder. It is freely soluble in anhydrous alcohol; slightly soluble in water; practically insoluble in heptane. Each film-coated tablet contains active ingredient 5 mg, 10 mg or 20 mg of vardenafil equivalent to 5.926 mg, 11.852 mg or 23.704 vardenafil hydrochloride trihydrate respectively which is equivalent to 5.373 mg, 10.746 mg or 21.492 mg of vardenafil hydrochloride respectively. Each film-coated tablet contains inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol, microcrystalline cellulose, sodium stearyl fumarate, talc and titanium dioxide."
},
{
"NDCCode": "70069-746-25",
"PackageDescription": "25 BOTTLE in 1 CARTON (70069-746-25) / 5 mL in 1 BOTTLE",
"NDC11Code": "70069-0746-25",
"ProductNDC": "70069-746",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Phosphate",
"NonProprietaryName": "Potassium Phosphate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217726",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE",
"StrengthNumber": "224; 236",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240711",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium phosphates injection is indicated as a source of phosphorus: 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated., 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.",
"Description": "Potassium phosphates injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials. Monobasic potassium phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic potassium phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water. Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route."
},
{
"NDCCode": "66096-011-32",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (66096-011-32) ",
"NDC11Code": "66096-0011-32",
"ProductNDC": "66096-011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anx-ohm",
"NonProprietaryName": "Argentum Nitricum, Avena Sativa, Aurum Metallicum, Gelsemium, Hyosciamus Niger, Ignatia, Moschus, Natrum Muriaticum, Passiflora Incarnata, Stannum Metallicum, Valeriana Officinalis",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20100101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "SILVER NITRATE; AVENA SATIVA FLOWERING TOP; GOLD; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; MOSCHUS MOSCHIFERUS WHOLE; SODIUM CHLORIDE; PASSIFLORA INCARNATA TOP; TIN; VALERIAN",
"StrengthNumber": "14; 5; 14; 14; 14; 14; 14; 14; 5; 16; 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; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2021-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100101",
"SamplePackage": "N"
}
]
}
{"NDC":[{"NDCCode":"66096-746-09","ProprietaryName":"Seagate Olive Leaf","NonProprietaryName":"Baptisia Tinctoria (wild Indigo)"},{"NDCCode":"66096-527-09","ProprietaryName":"Ohm Sinus Nasal","NonProprietaryName":"Aralia Rac, Euphorbium, Galphimia, Hepar Sulph Calc, Histaminum, Hydrastis, Kali Bic, Kali Iod, Luffa, Pulsatilla, Teucrium Mar."},{"NDCCode":"66096-158-05","ProprietaryName":"Allergy Relief","NonProprietaryName":"Allium Cepa, Apis Mellifica, Aralia Racemosa, Blatta Orientalis, Euphrasia Officinalis, Galphimia Glauca, Hedera Helix, Luffa Operculata, Okoubaka, Sabadilla."},{"NDCCode":"66096-678-02","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."},{"NDCCode":"66096-678-12","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."},{"NDCCode":"66096-682-02","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."},{"NDCCode":"66096-682-12","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."},{"NDCCode":"66096-683-02","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, 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<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<PackageDescription>30 mL in 1 BOTTLE, SPRAY (66096-527-09) </PackageDescription>
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<LabelerName>OHM PHARMA INC.</LabelerName>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDCCode>66096-158-05</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (66096-158-05)</PackageDescription>
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<StartMarketingDate>20150417</StartMarketingDate>
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<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>
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<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>
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<PackageDescription>30 mL in 1 BOTTLE, SPRAY (66096-678-02)</PackageDescription>
<NDC11Code>66096-0678-02</NDC11Code>
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<StartMarketingDate>20130701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
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<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>
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<NDCCode>66096-678-12</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE, SPRAY (66096-678-12)</PackageDescription>
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<ProductNDC>66096-678</ProductNDC>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20130701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
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<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>
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<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>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20130701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
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<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>
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<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>
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<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>11559-746-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (11559-746-01) > 30 mL in 1 BOTTLE (11559-746-02)</PackageDescription>
<NDC11Code>11559-0746-01</NDC11Code>
<ProductNDC>11559-746</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Renutriv</ProprietaryName>
<ProprietaryNameSuffix>Ultimate Radiance Makeup Spf 15</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>ESTEE LAUDER INC</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>2.2; 1.4</StrengthNumber>
<StrengthUnit>mL/100mL; mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>21695-746-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (21695-746-30)</PackageDescription>
<NDC11Code>21695-0746-30</NDC11Code>
<ProductNDC>21695-746</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glimepiride</ProprietaryName>
<NonProprietaryName>Glimepiride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077091</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>GLIMEPIRIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (See DOSAGE AND ADMINISTRATION section).</IndicationAndUsage>
<Description>Glimepiride tablets USP, are an oral blood-glucose-lowering drug of the sulfonylurea class. Glimepiride is a white to yellowish-white, crystalline, odorless to practically odorless powder formulated into tablets of 1 mg, 2 mg, and 4 mg strengths for oral administration. Glimepiride tablets contain the active ingredient glimepiride and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. In addition, glimepiride 1 mg tablets contain ferric oxide red, glimepiride 2 mg tablets contain lake blend green (contains D&C yellow # 10 aluminium lake and FD&C blue #1/ brilliant blue FCF aluminium lake) and glimepiride 4 mg tablets contain lake blend blue (contains D&C yellow # 10 aluminium lake and FD&C blue # 1/ brilliant blue FCF aluminium lake). Chemically, glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1- carboxamido)ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea. The CAS Registry Number is 93479-97-1. The structural formula is. Molecular Formula: C24H34N4O5S. Molecular Weight: 490.62. Glimepiride is practically insoluble in water.</Description>
</NDC>
<NDC>
<NDCCode>21695-746-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (21695-746-90)</PackageDescription>
<NDC11Code>21695-0746-90</NDC11Code>
<ProductNDC>21695-746</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glimepiride</ProprietaryName>
<NonProprietaryName>Glimepiride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077091</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>GLIMEPIRIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (See DOSAGE AND ADMINISTRATION section).</IndicationAndUsage>
<Description>Glimepiride tablets USP, are an oral blood-glucose-lowering drug of the sulfonylurea class. Glimepiride is a white to yellowish-white, crystalline, odorless to practically odorless powder formulated into tablets of 1 mg, 2 mg, and 4 mg strengths for oral administration. Glimepiride tablets contain the active ingredient glimepiride and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. In addition, glimepiride 1 mg tablets contain ferric oxide red, glimepiride 2 mg tablets contain lake blend green (contains D&C yellow # 10 aluminium lake and FD&C blue #1/ brilliant blue FCF aluminium lake) and glimepiride 4 mg tablets contain lake blend blue (contains D&C yellow # 10 aluminium lake and FD&C blue # 1/ brilliant blue FCF aluminium lake). Chemically, glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1- carboxamido)ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea. The CAS Registry Number is 93479-97-1. The structural formula is. Molecular Formula: C24H34N4O5S. Molecular Weight: 490.62. Glimepiride is practically insoluble in water.</Description>
</NDC>
<NDC>
<NDCCode>49527-746-01</NDCCode>
<PackageDescription>1 JAR in 1 CARTON (49527-746-01) > 18 g in 1 JAR (49527-746-02)</PackageDescription>
<NDC11Code>49527-0746-01</NDC11Code>
<ProductNDC>49527-746</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Superbalanced</ProprietaryName>
<ProprietaryNameSuffix>Makeup Spf 15 Mineral Rich Formula</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>CLINIQUE LABORATORIES INC.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>6.3</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51079-746-19</NDCCode>
<PackageDescription>25 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-746-19) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-746-17)</PackageDescription>
<NDC11Code>51079-0746-19</NDC11Code>
<ProductNDC>51079-746</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960307</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072838</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-09-25</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>52959-746-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (52959-746-30)</PackageDescription>
<NDC11Code>52959-0746-30</NDC11Code>
<ProductNDC>52959-746</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lyrica</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20041230</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021724</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>LYRICA is indicated for.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>52959-746-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (52959-746-60)</PackageDescription>
<NDC11Code>52959-0746-60</NDC11Code>
<ProductNDC>52959-746</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lyrica</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20041230</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021724</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>LYRICA is indicated for.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>52959-746-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (52959-746-90)</PackageDescription>
<NDC11Code>52959-0746-90</NDC11Code>
<ProductNDC>52959-746</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lyrica</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20041230</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021724</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>LYRICA is indicated for.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>55289-746-10</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE, PLASTIC (55289-746-10) </PackageDescription>
<NDC11Code>55289-0746-10</NDC11Code>
<ProductNDC>55289-746</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trimethoprim</ProprietaryName>
<NonProprietaryName>Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100404</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070049</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TRIMETHOPRIM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63868-746-07</NDCCode>
<PackageDescription>177 mL in 1 BOTTLE, PLASTIC (63868-746-07) </PackageDescription>
<NDC11Code>63868-0746-07</NDC11Code>
<ProductNDC>63868-746</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucus Relief Cold Flu And Sore Throat</ProprietaryName>
<ProprietaryNameSuffix>Maximum Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150131</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>QUALITY CHOICE (Chain Drug Marketing Association)</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>650; 20; 400; 10</StrengthNumber>
<StrengthUnit>mg/20mL; mg/20mL; mg/20mL; mg/20mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these common cold and flu symptoms:sinus congestion and pressureminor aches and painsnasal congestioncough due to minor throat and bronchial irritationsore throatheadache. temporarily reduces fever. temporarily promotes nasal and/or sinus drainage. helps loosen phlegm (mucus) amd thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68180-746-06</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (68180-746-06) </PackageDescription>
<NDC11Code>68180-0746-06</NDC11Code>
<ProductNDC>68180-746</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201211</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021695</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69238-1151-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (69238-1151-3) </PackageDescription>
<NDC11Code>69238-1151-03</NDC11Code>
<ProductNDC>69238-1151</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vardenafil Hydrochloride</ProprietaryName>
<NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181031</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210738</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>VARDENAFIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil hydrochloride is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride, trihydrate and has the following structural formula. Molecular weight - 579.11 g/mol. Molecular formula - C23H32N6O4S.HCl.3H2O. Vardenafil hydrochloride trihydrate is white or slightly brown or yellow powder. It is freely soluble in anhydrous alcohol; slightly soluble in water; practically insoluble in heptane. Each film-coated tablet contains active ingredient 5 mg, 10 mg or 20 mg of vardenafil equivalent to 5.926 mg, 11.852 mg or 23.704 vardenafil hydrochloride trihydrate respectively which is equivalent to 5.373 mg, 10.746 mg or 21.492 mg of vardenafil hydrochloride respectively. Each film-coated tablet contains inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol, microcrystalline cellulose, sodium stearyl fumarate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>69238-1152-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (69238-1152-3) </PackageDescription>
<NDC11Code>69238-1152-03</NDC11Code>
<ProductNDC>69238-1152</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vardenafil Hydrochloride</ProprietaryName>
<NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181031</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210738</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>VARDENAFIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil hydrochloride is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride, trihydrate and has the following structural formula. Molecular weight - 579.11 g/mol. Molecular formula - C23H32N6O4S.HCl.3H2O. Vardenafil hydrochloride trihydrate is white or slightly brown or yellow powder. It is freely soluble in anhydrous alcohol; slightly soluble in water; practically insoluble in heptane. Each film-coated tablet contains active ingredient 5 mg, 10 mg or 20 mg of vardenafil equivalent to 5.926 mg, 11.852 mg or 23.704 vardenafil hydrochloride trihydrate respectively which is equivalent to 5.373 mg, 10.746 mg or 21.492 mg of vardenafil hydrochloride respectively. Each film-coated tablet contains inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol, microcrystalline cellulose, sodium stearyl fumarate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>69238-1153-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (69238-1153-3) </PackageDescription>
<NDC11Code>69238-1153-03</NDC11Code>
<ProductNDC>69238-1153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vardenafil Hydrochloride</ProprietaryName>
<NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181031</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210738</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>VARDENAFIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil hydrochloride is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride, trihydrate and has the following structural formula. Molecular weight - 579.11 g/mol. Molecular formula - C23H32N6O4S.HCl.3H2O. Vardenafil hydrochloride trihydrate is white or slightly brown or yellow powder. It is freely soluble in anhydrous alcohol; slightly soluble in water; practically insoluble in heptane. Each film-coated tablet contains active ingredient 5 mg, 10 mg or 20 mg of vardenafil equivalent to 5.926 mg, 11.852 mg or 23.704 vardenafil hydrochloride trihydrate respectively which is equivalent to 5.373 mg, 10.746 mg or 21.492 mg of vardenafil hydrochloride respectively. Each film-coated tablet contains inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol, microcrystalline cellulose, sodium stearyl fumarate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70069-746-25</NDCCode>
<PackageDescription>25 BOTTLE in 1 CARTON (70069-746-25) / 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>70069-0746-25</NDC11Code>
<ProductNDC>70069-746</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Phosphate</ProprietaryName>
<NonProprietaryName>Potassium Phosphate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217726</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE</SubstanceName>
<StrengthNumber>224; 236</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium phosphates injection is indicated as a source of phosphorus: 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated., 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.</IndicationAndUsage>
<Description>Potassium phosphates injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials. Monobasic potassium phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic potassium phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water. Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route.</Description>
</NDC>
<NDC>
<NDCCode>66096-011-32</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (66096-011-32) </PackageDescription>
<NDC11Code>66096-0011-32</NDC11Code>
<ProductNDC>66096-011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anx-ohm</ProprietaryName>
<NonProprietaryName>Argentum Nitricum, Avena Sativa, Aurum Metallicum, Gelsemium, Hyosciamus Niger, Ignatia, Moschus, Natrum Muriaticum, Passiflora Incarnata, Stannum Metallicum, Valeriana Officinalis</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>SILVER NITRATE; AVENA SATIVA FLOWERING TOP; GOLD; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; MOSCHUS MOSCHIFERUS WHOLE; SODIUM CHLORIDE; PASSIFLORA INCARNATA TOP; TIN; VALERIAN</SubstanceName>
<StrengthNumber>14; 5; 14; 14; 14; 14; 14; 14; 5; 16; 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; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>
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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></NDC><NDC><NDCCode>66096-678-12</NDCCode><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></NDC><NDC><NDCCode>66096-682-02</NDCCode><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></NDC><NDC><NDCCode>66096-682-12</NDCCode><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></NDC><NDC><NDCCode>66096-683-02</NDCCode><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></NDC><NDC><NDCCode>66096-684-02</NDCCode><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></NDC><NDC><NDCCode>66096-685-02</NDCCode><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></NDC><NDC><NDCCode>66096-686-02</NDCCode><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></NDC><NDC><NDCCode>66096-687-02</NDCCode><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></NDC><NDC><NDCCode>66096-715-02</NDCCode><ProprietaryName>Rhus Tox 4x, 8x, 12x</ProprietaryName><NonProprietaryName>Rhus Toxicodendron.</NonProprietaryName></NDC><NDC><NDCCode>66096-716-02</NDCCode><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></NDC><NDC><NDCCode>11559-746-01</NDCCode><ProprietaryName>Renutriv</ProprietaryName><NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>21695-746-30</NDCCode><ProprietaryName>Glimepiride</ProprietaryName><NonProprietaryName>Glimepiride</NonProprietaryName></NDC><NDC><NDCCode>21695-746-90</NDCCode><ProprietaryName>Glimepiride</ProprietaryName><NonProprietaryName>Glimepiride</NonProprietaryName></NDC><NDC><NDCCode>49527-746-01</NDCCode><ProprietaryName>Superbalanced</ProprietaryName><NonProprietaryName>Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>51079-746-19</NDCCode><ProprietaryName>Diltiazem Hydrochloride</ProprietaryName><NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>52959-746-30</NDCCode><ProprietaryName>Lyrica</ProprietaryName><NonProprietaryName>Pregabalin</NonProprietaryName></NDC><NDC><NDCCode>52959-746-60</NDCCode><ProprietaryName>Lyrica</ProprietaryName><NonProprietaryName>Pregabalin</NonProprietaryName></NDC><NDC><NDCCode>52959-746-90</NDCCode><ProprietaryName>Lyrica</ProprietaryName><NonProprietaryName>Pregabalin</NonProprietaryName></NDC><NDC><NDCCode>55289-746-10</NDCCode><ProprietaryName>Trimethoprim</ProprietaryName><NonProprietaryName>Trimethoprim</NonProprietaryName></NDC><NDC><NDCCode>63868-746-07</NDCCode><ProprietaryName>Mucus Relief Cold Flu And Sore Throat</ProprietaryName><NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl</NonProprietaryName></NDC><NDC><NDCCode>68180-746-06</NDCCode><ProprietaryName>Fenofibrate</ProprietaryName><NonProprietaryName>Fenofibrate</NonProprietaryName></NDC><NDC><NDCCode>69238-1151-3</NDCCode><ProprietaryName>Vardenafil Hydrochloride</ProprietaryName><NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>69238-1152-3</NDCCode><ProprietaryName>Vardenafil Hydrochloride</ProprietaryName><NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>69238-1153-3</NDCCode><ProprietaryName>Vardenafil Hydrochloride</ProprietaryName><NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>70069-746-25</NDCCode><ProprietaryName>Potassium Phosphate</ProprietaryName><NonProprietaryName>Potassium Phosphate</NonProprietaryName></NDC><NDC><NDCCode>66096-011-32</NDCCode><ProprietaryName>Anx-ohm</ProprietaryName><NonProprietaryName>Argentum Nitricum, Avena Sativa, Aurum Metallicum, Gelsemium, Hyosciamus Niger, Ignatia, Moschus, Natrum Muriaticum, Passiflora Incarnata, Stannum Metallicum, Valeriana Officinalis</NonProprietaryName></NDC></NDCList>