{
"NDC": [
{
"NDCCode": "68428-749-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (68428-749-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-749-14)",
"NDC11Code": "68428-0749-29",
"ProductNDC": "68428-749",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Be Gone Skin Irritation",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Arsenic Trioxide - Calcium Sulfate Anhydrous - Sodium Phosphate, Dibasic, Heptahydrate - Silicon Dioxide",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140508",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ARSENIC TRIOXIDE; CALCIUM SULFATE ANHYDROUS; SILICON DIOXIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE",
"StrengthNumber": "6; 6; 6; 6",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"IndicationAndUsage": "Indications:. ARSENICUM ALB Scaley, red, dry. CALC SULPH Slow healing. NAT PHOS Smooth, red, shining. SILICEA Boils, waxy, painful scars."
},
{
"NDCCode": "68428-718-29",
"PackageDescription": "56 g in 1 TUBE (68428-718-29) ",
"NDC11Code": "68428-0718-29",
"ProductNDC": "68428-718",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Be Gone Bruises And Bumps",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Arnica Montana",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130315",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ARNICA MONTANA",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/56g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20130315",
"SamplePackage": "N",
"IndicationAndUsage": "Indications. ARNICA Bruising."
},
{
"NDCCode": "68428-719-29",
"PackageDescription": "56 g in 1 TUBE (68428-719-29) ",
"NDC11Code": "68428-0719-29",
"ProductNDC": "68428-719",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Be Gone Cuts And Scrapes",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Calendula Officinalis Flowering Top",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130315",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CALENDULA OFFICINALIS FLOWERING TOP",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/56g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20130315",
"SamplePackage": "N",
"IndicationAndUsage": "Indications. CALENDULA Promotes healing."
},
{
"NDCCode": "68428-720-29",
"PackageDescription": "56 g in 1 TUBE (68428-720-29) ",
"NDC11Code": "68428-0720-29",
"ProductNDC": "68428-720",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Be Gone Minor Arthritic Pain",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Arnica Montana - Rhus Toxicodendron - Ruta Graveolens",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130315",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ARNICA MONTANA; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "3; 3; 3",
"StrengthUnit": "[hp_X]/56g; [hp_X]/56g; [hp_X]/56g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20130315",
"SamplePackage": "N",
"IndicationAndUsage": "Indications. ARNICA MONTANA Bruises. RHUS TOXICODENDRON Better motion. RUTA GRAVEOLENS Bruised feeling."
},
{
"NDCCode": "68428-721-29",
"PackageDescription": "56 g in 1 TUBE (68428-721-29) ",
"NDC11Code": "68428-0721-29",
"ProductNDC": "68428-721",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Be Gone Scars",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Thiosinaminum",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130315",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ALLYLTHIOUREA",
"StrengthNumber": "2",
"StrengthUnit": "[hp_X]/56g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20130315",
"SamplePackage": "N",
"IndicationAndUsage": "Indications. THIOSINAMINUM Scarring."
},
{
"NDCCode": "68428-722-29",
"PackageDescription": "56 g in 1 TUBE (68428-722-29) ",
"NDC11Code": "68428-0722-29",
"ProductNDC": "68428-722",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Be Gone Warts And Tired Feet",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Thuja Occidentalis",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130315",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/56g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20130315",
"SamplePackage": "N",
"IndicationAndUsage": "Indications. THUJA OCCIDENTALIS Warts."
},
{
"NDCCode": "68428-725-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (68428-725-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-725-14) ",
"NDC11Code": "68428-0725-29",
"ProductNDC": "68428-725",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Be Gone Poison Ivy",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Toxicodendron Pubescens Leaf",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130228",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "4",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160419",
"SamplePackage": "N",
"IndicationAndUsage": "Indications:. RHUS TOX Better motion."
},
{
"NDCCode": "68428-726-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (68428-726-29) > 28 g in 1 BOTTLE, PLASTIC",
"NDC11Code": "68428-0726-29",
"ProductNDC": "68428-726",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Be Gone Insomnia",
"NonProprietaryName": "Matricaria Recutita - Arabica Coffee Bean - Hyoscyamus Niger - Strychnos Ignatii Seed - Strychnos Nux-vomica Seed -passiflora Incarnata Top",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ARABICA COFFEE BEAN; HYOSCYAMUS NIGER; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED",
"StrengthNumber": "6; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20130301",
"SamplePackage": "N",
"IndicationAndUsage": "Indications:. CHAMOMILLA Irritability. COFFEA CRUDA Sleeplessness. HYOSCYAMUS Twitching. IGNATIA Sadness. NUX VOMICA Vomiting. PASSIFLORA Insomnia."
},
{
"NDCCode": "68428-728-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (68428-728-29) > 28 g in 1 BOTTLE, PLASTIC (68428-728-14) ",
"NDC11Code": "68428-0728-29",
"ProductNDC": "68428-728",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Be Gone Minor Arthritic Pain",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Apis Mellifera, Black Cohosh, Calcium Fluoride, Sodium Phosphate, Dibasic, Heptahydrate, Toxicodendron Pubescens Leaf",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130228",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "APIS MELLIFERA; BLACK COHOSH; CALCIUM FLUORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "6; 6; 6; 6; 6",
"StrengthUnit": "[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g",
"Pharm_Classes": "Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20130228",
"SamplePackage": "N",
"IndicationAndUsage": "Indications:. APIS MEL Stiffness. CALC FLUOR Enlargement of joints. CIMICIFUGA Aching. NAT PHOS Pain in knees. RHUS TOX Minor arthritic pain."
},
{
"NDCCode": "68428-730-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (68428-730-29) > 28 g in 1 BOTTLE, PLASTIC (68428-730-14) ",
"NDC11Code": "68428-0730-29",
"ProductNDC": "68428-730",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Be Gone Sinus Congestion",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Oyster Shell Calcium Carbonate, Crude - Goldenseal - Potassium Dichromate",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130228",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "GOLDENSEAL; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM DICHROMATE",
"StrengthNumber": "6; 6; 6",
"StrengthUnit": "[hp_C]/28g; [hp_C]/28g; [hp_C]/28g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20130228",
"SamplePackage": "N",
"IndicationAndUsage": "Indications:. CALC CARB - OVERWORK. HYDRASTIS - SINUSES. KALI BIC - SINUSES."
},
{
"NDCCode": "68428-731-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (68428-731-29) > 28 g in 1 BOTTLE, PLASTIC",
"NDC11Code": "68428-0731-29",
"ProductNDC": "68428-731",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Be Gone Smoking",
"NonProprietaryName": "Dieffenbachia Seguine - Daphne Odora Bark - Strychnos Nux-vomica Seed - Plantago Major - Delphinium Staphisagria Seed - Tobacco Leaf",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "DAPHNE ODORA BARK; DELPHINIUM STAPHISAGRIA SEED; DIEFFENBACHIA SEGUINE; PLANTAGO MAJOR; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF",
"StrengthNumber": "6; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20130301",
"SamplePackage": "N",
"IndicationAndUsage": "Indications. CALADIUM Motion sickness. DAPHNE Bad breath. NUX VOM Vomiting. PLANTAGO Earache. STAPHYSAG Anger. TABACUM Sea sickness."
},
{
"NDCCode": "68428-745-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (68428-745-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-745-14)",
"NDC11Code": "68428-0745-29",
"ProductNDC": "68428-745",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Be Gone Diarrhea",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Arsenic Trioxide - Cupric Arsenite - Veratrum Album Root",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140508",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ARSENIC TRIOXIDE; CUPRIC ARSENITE; VERATRUM ALBUM ROOT",
"StrengthNumber": "6; 6; 6",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"IndicationAndUsage": "Indications:. Arsenicum alb 6c –small, offensive stool*. Cuprum ars 6c –watery stool*. Veratrum alb 6c –large stool*. ■ Cramps* ■ Vomiting* ■ Spasmodic pains*. *These statements have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "68428-746-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 PACKAGE (68428-746-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-746-14)",
"NDC11Code": "68428-0746-29",
"ProductNDC": "68428-746",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Be Gone Flatulence",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Ferula Assa-foetida Resin, Strychnos Ignatii Seed, Nutmeg",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140508",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "FERULA ASSA-FOETIDA RESIN; NUTMEG; STRYCHNOS IGNATII SEED",
"StrengthNumber": "6; 6; 6",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"IndicationAndUsage": "Indications. Asafoetida 6c –offensive odor*. Ignatia 6c –much flatulence*. Nux mosch 6c –indigestion/bloating*. ■ Bloating* ■ Gas* ■ Sour stomach* ■ Heartburn*. *These statements have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "68428-747-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (68428-747-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-747-14)",
"NDC11Code": "68428-0747-29",
"ProductNDC": "68428-747",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Be Gone Congested Headache",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Calcium Fluoride - Ferrosoferric Phosphate - Sodium Phosphate, Dibasic, Heptahydrate - Sodium Chloride",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140508",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CALCIUM FLUORIDE; FERROSOFERRIC PHOSPHATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE",
"StrengthNumber": "6; 6; 6; 6",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"IndicationAndUsage": "Indications. Calc fluor 6c –cracking noise*. Ferrum phos 6c –worse motion*. Nat phos 6c –throbbing headache*. Nat mur 6c –blinding headache*. ■ Weakness* ■ Dizziness* ■ Stress-related*. *These statements have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "68428-748-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (68428-748-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-748-14)",
"NDC11Code": "68428-0748-29",
"ProductNDC": "68428-748",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Be Gone Painful Urination",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Berberis Vulgaris Root Bark - Turpentine Oil - Lycopodium Clavatum Spore",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140508",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "BERBERIS VULGARIS ROOT BARK; TURPENTINE OIL; LYCOPODIUM CLAVATUM SPORE",
"StrengthNumber": "6; 6; 6",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Indications:. BERBER VULG Burning pains. TEREBINTHINA Frequent urging. LYCOPODIUM Hot urine."
},
{
"NDCCode": "68428-862-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 PACKAGE (68428-862-29) > 12000 PELLET in 1 BOTTLE, PLASTIC (68428-862-14)",
"NDC11Code": "68428-0862-29",
"ProductNDC": "68428-862",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Be Gone Teething",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Tribasic Calcium Phosphate - Matricaria Chamomilla - Arabica Coffee Bean",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140508",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ARABICA COFFEE BEAN; MATRICARIA CHAMOMILLA; TRIBASIC CALCIUM PHOSPHATE",
"StrengthNumber": "6; 6; 6",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1",
"Pharm_Classes": "Allergens [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"IndicationAndUsage": "Indications:. Calc phos 6c –troubled teething*. Chamomilla 6c –distressed teething*. Coffea cruda 6c –sensitive teething*. ■ Irritability ■ Restlessness ■ Sleeplessness. *These statements have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "68428-997-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 PACKAGE (68428-997-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-997-14)",
"NDC11Code": "68428-0997-29",
"ProductNDC": "68428-997",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Be Gone Hangover",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Activated Charcoal, Arabica Coffee Bean, Ipecac, Strychnos Nux-vomica Seed",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160513",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ACTIVATED CHARCOAL; ARABICA COFFEE BEAN; IPECAC; STRYCHNOS NUX-VOMICA SEED",
"StrengthNumber": "6; 6; 6; 6",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"IndicationAndUsage": "Indications. Carbo veg 6c –effects of alcohol*. Coffea cruda 6c –headache*. Ipecac 6c –nausea*. Nux vom 6c –over-indulgence*. ■ Nausea* ■ Loss of appetite* ■ Headache*. *These statements have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "68428-998-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 PACKAGE (68428-998-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-998-14)",
"NDC11Code": "68428-0998-29",
"ProductNDC": "68428-998",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Be Gone Stings",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Apis Mellifera, Arabica Coffee Bean, Ipecac, Strychnos Nux-vomica Seed",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160513",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "APIS MELLIFERA; HYPERICUM PERFORATUM; RHODODENDRON TOMENTOSUM LEAFY TWIG; URTICA URENS",
"StrengthNumber": "6; 6; 6; 6",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1",
"Pharm_Classes": "Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"IndicationAndUsage": "Indications. Apis mel 30c –stinging pains*. Hypericum 30c –insect bites*. Ledum 30c –insect bites*. Urtica ur 30c –bee stings*. ■ Insect bites ■ Bee stings ■ Mosquito bites. *These statements have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "68428-999-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 PACKAGE (68428-999-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-999-14)",
"NDC11Code": "68428-0999-29",
"ProductNDC": "68428-999",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Be Gone Stress",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Helianthemum Nummularium Flower, Impatiens Glandulifera Flower, Olea Europaea Flower, Ornithogalum Umbellatum Flowering Top, Prunus Cerasifera Flower",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160513",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; OLEA EUROPAEA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER",
"StrengthNumber": "5; 5; 5; 5; 5",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Indications. Helianthemum num, flos 5x (Rock Rose) –acute anxiety*. Impatiens glan, flos 5x (Impatiens) –impatience*. Olea eur, flos 5x (Olive) –mental fatigue*. Ornithogalum umbellatum, flos 5x (Star of Bethlehem) –after effects of shock*. Prunus cera, flos 5x (Cherry Plum) –desperation. ■ Fear and worrying ■ Impatience ■ Feeling overwhelmed ■ Stage fright. *These statements have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "0264-3200-55",
"PackageDescription": "6 CARTON in 1 CASE (0264-3200-55) > 1 BOTTLE, GLASS in 1 CARTON > 1000 mL in 1 BOTTLE, GLASS",
"NDC11Code": "00264-3200-55",
"ProductNDC": "0264-3200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Plenamine",
"NonProprietaryName": "Lysine Acetate, Leucine, Phenylalanine, Valine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Histidine, Proline, Glutamic Acid, Serine, Aspartic Acid, And Tyrosine",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091112",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE",
"StrengthNumber": "2.17; 1.47; 434; 749; 1.04; 894; 749; 1.04; 1.18; 749; 1.04; 894; 592; 749; 250; 39; 960",
"StrengthUnit": "g/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20150130",
"SamplePackage": "N"
},
{
"NDCCode": "0264-3205-55",
"PackageDescription": "6 CARTON in 1 CASE (0264-3205-55) > 1 BOTTLE, GLASS in 1 CARTON > 2000 mL in 1 BOTTLE, GLASS",
"NDC11Code": "00264-3205-55",
"ProductNDC": "0264-3205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Plenamine",
"NonProprietaryName": "Lysine Acetate, Leucine, Phenylalanine, Valine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Histidine, Proline, Glutamic Acid, Serine, Aspartic Acid, And Tyrosine",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091112",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE",
"StrengthNumber": "2.17; 1.47; 434; 749; 1.04; 894; 749; 1.04; 1.18; 749; 1.04; 894; 592; 749; 250; 39; 960",
"StrengthUnit": "g/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20150130",
"SamplePackage": "N"
},
{
"NDCCode": "16714-749-01",
"PackageDescription": "1 VIAL in 1 CARTON (16714-749-01) > 20 mL in 1 VIAL",
"NDC11Code": "16714-0749-01",
"ProductNDC": "16714-749",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Decitabine",
"NonProprietaryName": "Decitabine",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20171120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208601",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "DECITABINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-03-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20171120",
"SamplePackage": "N"
},
{
"NDCCode": "50090-8017-0",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (50090-8017-0) / 3 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "50090-8017-00",
"ProductNDC": "50090-8017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180705",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207398",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260720",
"SamplePackage": "N",
"IndicationAndUsage": "Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].",
"Description": "Azithromycin tablets USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white or almost white powder with a molecular formula of C38H72N2O122H2O and a molecular weight of 785.0. Azithromycin is supplied as tablets containing azithromycin dihydrate USP equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lactose monohydrate, pregelatinized starch (maize), magnesium stearate, sodium lauryl sulfate, titanium dioxide and triacetin."
},
{
"NDCCode": "61786-749-02",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (61786-749-02)",
"NDC11Code": "61786-0749-02",
"ProductNDC": "61786-749",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160616",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090960",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-11-29",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "62332-252-03",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (62332-252-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "62332-0252-03",
"ProductNDC": "62332-252",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211792",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2026-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200129",
"SamplePackage": "N",
"IndicationAndUsage": "Azithromycin tablets are a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1), 2 Acute bacterial sinusitis in adults (1.1) , 3 Uncomplicated skin and skin structure infections in adults (1.1) , 4 Urethritis and cervicitis in adults (1.1) , 5 Genital ulcer disease in men (1.1) , 6 Acute otitis media in pediatric patients (6 months of age and older) (1.2) , 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2) , 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2).",
"Description": "Azithromycin tablets, USP contain the active ingredient azithromycin, USP a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula. Azithromycin as the dihydrate, is a white or almost white powder with a molecular formula of C38H72N2O122H2O and a molecular weight of 785.02. Azithromycin tablets, USP are supplied for oral administration as pink modified capsule shaped, film-coated tablets containing azithromycin dihydrate equivalent to 500 mg azithromycin, USP and the following inactive ingredients: anhydrous dibasic calcium phosphate, croscarmellose sodium, D&C Red #30 Aluminum Lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide and triacetin. FDA approved dissolution specification differs from the USP dissolution specification."
},
{
"NDCCode": "62332-252-09",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (62332-252-09) / 3 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "62332-0252-09",
"ProductNDC": "62332-252",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211792",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2026-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200129",
"SamplePackage": "N",
"IndicationAndUsage": "Azithromycin tablets are a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1), 2 Acute bacterial sinusitis in adults (1.1) , 3 Uncomplicated skin and skin structure infections in adults (1.1) , 4 Urethritis and cervicitis in adults (1.1) , 5 Genital ulcer disease in men (1.1) , 6 Acute otitis media in pediatric patients (6 months of age and older) (1.2) , 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2) , 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2).",
"Description": "Azithromycin tablets, USP contain the active ingredient azithromycin, USP a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula. Azithromycin as the dihydrate, is a white or almost white powder with a molecular formula of C38H72N2O122H2O and a molecular weight of 785.02. Azithromycin tablets, USP are supplied for oral administration as pink modified capsule shaped, film-coated tablets containing azithromycin dihydrate equivalent to 500 mg azithromycin, USP and the following inactive ingredients: anhydrous dibasic calcium phosphate, croscarmellose sodium, D&C Red #30 Aluminum Lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide and triacetin. FDA approved dissolution specification differs from the USP dissolution specification."
},
{
"NDCCode": "62332-252-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (62332-252-30) ",
"NDC11Code": "62332-0252-30",
"ProductNDC": "62332-252",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211792",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2026-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200129",
"SamplePackage": "N",
"IndicationAndUsage": "Azithromycin tablets are a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1), 2 Acute bacterial sinusitis in adults (1.1) , 3 Uncomplicated skin and skin structure infections in adults (1.1) , 4 Urethritis and cervicitis in adults (1.1) , 5 Genital ulcer disease in men (1.1) , 6 Acute otitis media in pediatric patients (6 months of age and older) (1.2) , 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2) , 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2).",
"Description": "Azithromycin tablets, USP contain the active ingredient azithromycin, USP a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula. Azithromycin as the dihydrate, is a white or almost white powder with a molecular formula of C38H72N2O122H2O and a molecular weight of 785.02. Azithromycin tablets, USP are supplied for oral administration as pink modified capsule shaped, film-coated tablets containing azithromycin dihydrate equivalent to 500 mg azithromycin, USP and the following inactive ingredients: anhydrous dibasic calcium phosphate, croscarmellose sodium, D&C Red #30 Aluminum Lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide and triacetin. FDA approved dissolution specification differs from the USP dissolution specification."
},
{
"NDCCode": "67046-1502-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1502-3) ",
"NDC11Code": "67046-1502-03",
"ProductNDC": "67046-1502",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin Dihydrate",
"NonProprietaryName": "Azithromycin Dihydrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208250",
"LabelerName": "Coupler LLC",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250128",
"SamplePackage": "N",
"IndicationAndUsage": "Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].",
"Description": "Azithromycin Tablets, USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2- ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranos yl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O122H2O and a molecular weight of 785.0. Azithromycin is supplied as tablets containing azithromycin dihydrate equivalent to 250 mg azithromycin and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Blue #1 aluminum lake and lecithin, FD&C Red #40 aluminum Lake, FD&C Yellow #6 aluminum Lake, macrogol/PEG, magnesium stearate, polyvinyl alcohol, pregelatinized starch, talc, and titanium dioxide."
},
{
"NDCCode": "67046-1503-3",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (67046-1503-3) ",
"NDC11Code": "67046-1503-03",
"ProductNDC": "67046-1503",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin Dihydrate",
"NonProprietaryName": "Azithromycin Dihydrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065400",
"LabelerName": "Coupler LLC",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250128",
"SamplePackage": "N",
"IndicationAndUsage": "Azithromycin tablets are a macrolide antibacterial indicated for mild to moderate infections caused by designated, susceptible bacteria: 1 Mycobacterial Infections ( 1.2) .",
"Description": "Azithromycin tablets USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name ( 2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3- C-methyl-3- O-methyl-α -L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β- D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38H 72N 2O 12, and its molecular weight is 749.0. Azithromycin has the following structural formula:. Azithromycin, as the dihydrate, is a white to almost white crystalline powder with a molecular formula of C 38H 72N 2O 122H 2O and a molecular weight of 785.02. Azithromycin tablets USP contain azithromycin dihydrate equivalent to 600 mg azithromycin. They also contain the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl methyl cellulose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide and triacetin. Organic Impurities Test Pending."
},
{
"NDCCode": "67296-1942-2",
"PackageDescription": "2 CARTON in 1 BOX (67296-1942-2) / 1 BLISTER PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "67296-1942-02",
"ProductNDC": "67296-1942",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin Dihydrate",
"NonProprietaryName": "Azithromycin Dihydrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208249",
"LabelerName": "Redpharm Drug",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2025-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240215",
"SamplePackage": "N",
"IndicationAndUsage": "Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].",
"Description": "Azithromycin Tablets, USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38H 72N 2O 12, and its molecular weight is 749.00. Azithromycin has the following structural formula:. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 12∙2H 2O and a molecular weight of 785.0. Azithromycin is supplied as tablets containing azithromycin dihydrate equivalent to 500 mg azithromycin and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Blue #1 aluminum lake and lecithin, FD&C Red #40 aluminum Lake, FD&C Yellow #6 aluminum Lake, macrogol/PEG, magnesium stearate, polyvinyl alcohol, pregelatinized starch, talc, and titanium dioxide."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>68428-749-29</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (68428-749-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-749-14)</PackageDescription>
<NDC11Code>68428-0749-29</NDC11Code>
<ProductNDC>68428-749</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whp Be Gone Skin Irritation</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Arsenic Trioxide - Calcium Sulfate Anhydrous - Sodium Phosphate, Dibasic, Heptahydrate - Silicon Dioxide</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140508</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>ARSENIC TRIOXIDE; CALCIUM SULFATE ANHYDROUS; SILICON DIOXIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE</SubstanceName>
<StrengthNumber>6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications:. ARSENICUM ALB Scaley, red, dry. CALC SULPH Slow healing. NAT PHOS Smooth, red, shining. SILICEA Boils, waxy, painful scars.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-718-29</NDCCode>
<PackageDescription>56 g in 1 TUBE (68428-718-29) </PackageDescription>
<NDC11Code>68428-0718-29</NDC11Code>
<ProductNDC>68428-718</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Be Gone Bruises And Bumps</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Arnica Montana</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130315</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>ARNICA MONTANA</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/56g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications. ARNICA Bruising.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-719-29</NDCCode>
<PackageDescription>56 g in 1 TUBE (68428-719-29) </PackageDescription>
<NDC11Code>68428-0719-29</NDC11Code>
<ProductNDC>68428-719</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Be Gone Cuts And Scrapes</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Calendula Officinalis Flowering Top</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130315</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>CALENDULA OFFICINALIS FLOWERING TOP</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/56g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications. CALENDULA Promotes healing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-720-29</NDCCode>
<PackageDescription>56 g in 1 TUBE (68428-720-29) </PackageDescription>
<NDC11Code>68428-0720-29</NDC11Code>
<ProductNDC>68428-720</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Be Gone Minor Arthritic Pain</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Arnica Montana - Rhus Toxicodendron - Ruta Graveolens</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130315</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>ARNICA MONTANA; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/56g; [hp_X]/56g; [hp_X]/56g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications. ARNICA MONTANA Bruises. RHUS TOXICODENDRON Better motion. RUTA GRAVEOLENS Bruised feeling.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-721-29</NDCCode>
<PackageDescription>56 g in 1 TUBE (68428-721-29) </PackageDescription>
<NDC11Code>68428-0721-29</NDC11Code>
<ProductNDC>68428-721</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Be Gone Scars</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Thiosinaminum</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130315</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>ALLYLTHIOUREA</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>[hp_X]/56g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications. THIOSINAMINUM Scarring.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-722-29</NDCCode>
<PackageDescription>56 g in 1 TUBE (68428-722-29) </PackageDescription>
<NDC11Code>68428-0722-29</NDC11Code>
<ProductNDC>68428-722</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Be Gone Warts And Tired Feet</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Thuja Occidentalis</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130315</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/56g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications. THUJA OCCIDENTALIS Warts.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-725-29</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (68428-725-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-725-14) </PackageDescription>
<NDC11Code>68428-0725-29</NDC11Code>
<ProductNDC>68428-725</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Be Gone Poison Ivy</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Toxicodendron Pubescens Leaf</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130228</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications:. RHUS TOX Better motion.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-726-29</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (68428-726-29) > 28 g in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>68428-0726-29</NDC11Code>
<ProductNDC>68428-726</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Be Gone Insomnia</ProprietaryName>
<NonProprietaryName>Matricaria Recutita - Arabica Coffee Bean - Hyoscyamus Niger - Strychnos Ignatii Seed - Strychnos Nux-vomica Seed -passiflora Incarnata Top</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>ARABICA COFFEE BEAN; HYOSCYAMUS NIGER; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications:. CHAMOMILLA Irritability. COFFEA CRUDA Sleeplessness. HYOSCYAMUS Twitching. IGNATIA Sadness. NUX VOMICA Vomiting. PASSIFLORA Insomnia.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-728-29</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (68428-728-29) > 28 g in 1 BOTTLE, PLASTIC (68428-728-14) </PackageDescription>
<NDC11Code>68428-0728-29</NDC11Code>
<ProductNDC>68428-728</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whp Be Gone Minor Arthritic Pain</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Apis Mellifera, Black Cohosh, Calcium Fluoride, Sodium Phosphate, Dibasic, Heptahydrate, Toxicodendron Pubescens Leaf</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130228</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>APIS MELLIFERA; BLACK COHOSH; CALCIUM FLUORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications:. APIS MEL Stiffness. CALC FLUOR Enlargement of joints. CIMICIFUGA Aching. NAT PHOS Pain in knees. RHUS TOX Minor arthritic pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-730-29</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (68428-730-29) > 28 g in 1 BOTTLE, PLASTIC (68428-730-14) </PackageDescription>
<NDC11Code>68428-0730-29</NDC11Code>
<ProductNDC>68428-730</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Be Gone Sinus Congestion</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Oyster Shell Calcium Carbonate, Crude - Goldenseal - Potassium Dichromate</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130228</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>GOLDENSEAL; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM DICHROMATE</SubstanceName>
<StrengthNumber>6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/28g; [hp_C]/28g; [hp_C]/28g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications:. CALC CARB - OVERWORK. HYDRASTIS - SINUSES. KALI BIC - SINUSES.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-731-29</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (68428-731-29) > 28 g in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>68428-0731-29</NDC11Code>
<ProductNDC>68428-731</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Be Gone Smoking</ProprietaryName>
<NonProprietaryName>Dieffenbachia Seguine - Daphne Odora Bark - Strychnos Nux-vomica Seed - Plantago Major - Delphinium Staphisagria Seed - Tobacco Leaf</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>DAPHNE ODORA BARK; DELPHINIUM STAPHISAGRIA SEED; DIEFFENBACHIA SEGUINE; PLANTAGO MAJOR; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications. CALADIUM Motion sickness. DAPHNE Bad breath. NUX VOM Vomiting. PLANTAGO Earache. STAPHYSAG Anger. TABACUM Sea sickness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-745-29</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (68428-745-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-745-14)</PackageDescription>
<NDC11Code>68428-0745-29</NDC11Code>
<ProductNDC>68428-745</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whp Be Gone Diarrhea</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Arsenic Trioxide - Cupric Arsenite - Veratrum Album Root</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140508</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>ARSENIC TRIOXIDE; CUPRIC ARSENITE; VERATRUM ALBUM ROOT</SubstanceName>
<StrengthNumber>6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/1; [hp_C]/1; [hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications:. Arsenicum alb 6c –small, offensive stool*. Cuprum ars 6c –watery stool*. Veratrum alb 6c –large stool*. ■ Cramps* ■ Vomiting* ■ Spasmodic pains*. *These statements have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-746-29</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 PACKAGE (68428-746-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-746-14)</PackageDescription>
<NDC11Code>68428-0746-29</NDC11Code>
<ProductNDC>68428-746</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whp Be Gone Flatulence</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Ferula Assa-foetida Resin, Strychnos Ignatii Seed, Nutmeg</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140508</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>FERULA ASSA-FOETIDA RESIN; NUTMEG; STRYCHNOS IGNATII SEED</SubstanceName>
<StrengthNumber>6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/1; [hp_C]/1; [hp_C]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications. Asafoetida 6c –offensive odor*. Ignatia 6c –much flatulence*. Nux mosch 6c –indigestion/bloating*. ■ Bloating* ■ Gas* ■ Sour stomach* ■ Heartburn*. *These statements have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-747-29</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (68428-747-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-747-14)</PackageDescription>
<NDC11Code>68428-0747-29</NDC11Code>
<ProductNDC>68428-747</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whp Be Gone Congested Headache</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Calcium Fluoride - Ferrosoferric Phosphate - Sodium Phosphate, Dibasic, Heptahydrate - Sodium Chloride</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140508</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>CALCIUM FLUORIDE; FERROSOFERRIC PHOSPHATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE</SubstanceName>
<StrengthNumber>6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications. Calc fluor 6c –cracking noise*. Ferrum phos 6c –worse motion*. Nat phos 6c –throbbing headache*. Nat mur 6c –blinding headache*. ■ Weakness* ■ Dizziness* ■ Stress-related*. *These statements have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-748-29</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (68428-748-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-748-14)</PackageDescription>
<NDC11Code>68428-0748-29</NDC11Code>
<ProductNDC>68428-748</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whp Be Gone Painful Urination</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Berberis Vulgaris Root Bark - Turpentine Oil - Lycopodium Clavatum Spore</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140508</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>BERBERIS VULGARIS ROOT BARK; TURPENTINE OIL; LYCOPODIUM CLAVATUM SPORE</SubstanceName>
<StrengthNumber>6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/1; [hp_C]/1; [hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications:. BERBER VULG Burning pains. TEREBINTHINA Frequent urging. LYCOPODIUM Hot urine.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-862-29</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 PACKAGE (68428-862-29) > 12000 PELLET in 1 BOTTLE, PLASTIC (68428-862-14)</PackageDescription>
<NDC11Code>68428-0862-29</NDC11Code>
<ProductNDC>68428-862</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whp Be Gone Teething</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Tribasic Calcium Phosphate - Matricaria Chamomilla - Arabica Coffee Bean</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140508</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>ARABICA COFFEE BEAN; MATRICARIA CHAMOMILLA; TRIBASIC CALCIUM PHOSPHATE</SubstanceName>
<StrengthNumber>6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/1; [hp_C]/1; [hp_C]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications:. Calc phos 6c –troubled teething*. Chamomilla 6c –distressed teething*. Coffea cruda 6c –sensitive teething*. ■ Irritability ■ Restlessness ■ Sleeplessness. *These statements have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-997-29</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 PACKAGE (68428-997-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-997-14)</PackageDescription>
<NDC11Code>68428-0997-29</NDC11Code>
<ProductNDC>68428-997</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whp Be Gone Hangover</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Activated Charcoal, Arabica Coffee Bean, Ipecac, Strychnos Nux-vomica Seed</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160513</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>ACTIVATED CHARCOAL; ARABICA COFFEE BEAN; IPECAC; STRYCHNOS NUX-VOMICA SEED</SubstanceName>
<StrengthNumber>6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications. Carbo veg 6c –effects of alcohol*. Coffea cruda 6c –headache*. Ipecac 6c –nausea*. Nux vom 6c –over-indulgence*. ■ Nausea* ■ Loss of appetite* ■ Headache*. *These statements have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-998-29</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 PACKAGE (68428-998-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-998-14)</PackageDescription>
<NDC11Code>68428-0998-29</NDC11Code>
<ProductNDC>68428-998</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whp Be Gone Stings</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Apis Mellifera, Arabica Coffee Bean, Ipecac, Strychnos Nux-vomica Seed</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160513</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>APIS MELLIFERA; HYPERICUM PERFORATUM; RHODODENDRON TOMENTOSUM LEAFY TWIG; URTICA URENS</SubstanceName>
<StrengthNumber>6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications. Apis mel 30c –stinging pains*. Hypericum 30c –insect bites*. Ledum 30c –insect bites*. Urtica ur 30c –bee stings*. ■ Insect bites ■ Bee stings ■ Mosquito bites. *These statements have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-999-29</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 PACKAGE (68428-999-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-999-14)</PackageDescription>
<NDC11Code>68428-0999-29</NDC11Code>
<ProductNDC>68428-999</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whp Be Gone Stress</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Helianthemum Nummularium Flower, Impatiens Glandulifera Flower, Olea Europaea Flower, Ornithogalum Umbellatum Flowering Top, Prunus Cerasifera Flower</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160513</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; OLEA EUROPAEA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER</SubstanceName>
<StrengthNumber>5; 5; 5; 5; 5</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications. Helianthemum num, flos 5x (Rock Rose) –acute anxiety*. Impatiens glan, flos 5x (Impatiens) –impatience*. Olea eur, flos 5x (Olive) –mental fatigue*. Ornithogalum umbellatum, flos 5x (Star of Bethlehem) –after effects of shock*. Prunus cera, flos 5x (Cherry Plum) –desperation. ■ Fear and worrying ■ Impatience ■ Feeling overwhelmed ■ Stage fright. *These statements have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0264-3200-55</NDCCode>
<PackageDescription>6 CARTON in 1 CASE (0264-3200-55) > 1 BOTTLE, GLASS in 1 CARTON > 1000 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>00264-3200-55</NDC11Code>
<ProductNDC>0264-3200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Plenamine</ProprietaryName>
<NonProprietaryName>Lysine Acetate, Leucine, Phenylalanine, Valine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Histidine, Proline, Glutamic Acid, Serine, Aspartic Acid, And Tyrosine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091112</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE</SubstanceName>
<StrengthNumber>2.17; 1.47; 434; 749; 1.04; 894; 749; 1.04; 1.18; 749; 1.04; 894; 592; 749; 250; 39; 960</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0264-3205-55</NDCCode>
<PackageDescription>6 CARTON in 1 CASE (0264-3205-55) > 1 BOTTLE, GLASS in 1 CARTON > 2000 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>00264-3205-55</NDC11Code>
<ProductNDC>0264-3205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Plenamine</ProprietaryName>
<NonProprietaryName>Lysine Acetate, Leucine, Phenylalanine, Valine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Histidine, Proline, Glutamic Acid, Serine, Aspartic Acid, And Tyrosine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091112</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE</SubstanceName>
<StrengthNumber>2.17; 1.47; 434; 749; 1.04; 894; 749; 1.04; 1.18; 749; 1.04; 894; 592; 749; 250; 39; 960</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16714-749-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (16714-749-01) > 20 mL in 1 VIAL</PackageDescription>
<NDC11Code>16714-0749-01</NDC11Code>
<ProductNDC>16714-749</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Decitabine</ProprietaryName>
<NonProprietaryName>Decitabine</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20171120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208601</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>DECITABINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50090-8017-0</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (50090-8017-0) / 3 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50090-8017-00</NDC11Code>
<ProductNDC>50090-8017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180705</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207398</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>Azithromycin tablets USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white or almost white powder with a molecular formula of C38H72N2O122H2O and a molecular weight of 785.0. Azithromycin is supplied as tablets containing azithromycin dihydrate USP equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lactose monohydrate, pregelatinized starch (maize), magnesium stearate, sodium lauryl sulfate, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>61786-749-02</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (61786-749-02)</PackageDescription>
<NDC11Code>61786-0749-02</NDC11Code>
<ProductNDC>61786-749</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160616</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090960</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-29</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>62332-252-03</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (62332-252-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>62332-0252-03</NDC11Code>
<ProductNDC>62332-252</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211792</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azithromycin tablets are a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1), 2 Acute bacterial sinusitis in adults (1.1) , 3 Uncomplicated skin and skin structure infections in adults (1.1) , 4 Urethritis and cervicitis in adults (1.1) , 5 Genital ulcer disease in men (1.1) , 6 Acute otitis media in pediatric patients (6 months of age and older) (1.2) , 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2) , 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2).</IndicationAndUsage>
<Description>Azithromycin tablets, USP contain the active ingredient azithromycin, USP a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula. Azithromycin as the dihydrate, is a white or almost white powder with a molecular formula of C38H72N2O122H2O and a molecular weight of 785.02. Azithromycin tablets, USP are supplied for oral administration as pink modified capsule shaped, film-coated tablets containing azithromycin dihydrate equivalent to 500 mg azithromycin, USP and the following inactive ingredients: anhydrous dibasic calcium phosphate, croscarmellose sodium, D&C Red #30 Aluminum Lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide and triacetin. FDA approved dissolution specification differs from the USP dissolution specification.</Description>
</NDC>
<NDC>
<NDCCode>62332-252-09</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (62332-252-09) / 3 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>62332-0252-09</NDC11Code>
<ProductNDC>62332-252</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211792</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azithromycin tablets are a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1), 2 Acute bacterial sinusitis in adults (1.1) , 3 Uncomplicated skin and skin structure infections in adults (1.1) , 4 Urethritis and cervicitis in adults (1.1) , 5 Genital ulcer disease in men (1.1) , 6 Acute otitis media in pediatric patients (6 months of age and older) (1.2) , 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2) , 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2).</IndicationAndUsage>
<Description>Azithromycin tablets, USP contain the active ingredient azithromycin, USP a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula. Azithromycin as the dihydrate, is a white or almost white powder with a molecular formula of C38H72N2O122H2O and a molecular weight of 785.02. Azithromycin tablets, USP are supplied for oral administration as pink modified capsule shaped, film-coated tablets containing azithromycin dihydrate equivalent to 500 mg azithromycin, USP and the following inactive ingredients: anhydrous dibasic calcium phosphate, croscarmellose sodium, D&C Red #30 Aluminum Lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide and triacetin. FDA approved dissolution specification differs from the USP dissolution specification.</Description>
</NDC>
<NDC>
<NDCCode>62332-252-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (62332-252-30) </PackageDescription>
<NDC11Code>62332-0252-30</NDC11Code>
<ProductNDC>62332-252</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211792</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azithromycin tablets are a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1), 2 Acute bacterial sinusitis in adults (1.1) , 3 Uncomplicated skin and skin structure infections in adults (1.1) , 4 Urethritis and cervicitis in adults (1.1) , 5 Genital ulcer disease in men (1.1) , 6 Acute otitis media in pediatric patients (6 months of age and older) (1.2) , 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2) , 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2).</IndicationAndUsage>
<Description>Azithromycin tablets, USP contain the active ingredient azithromycin, USP a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula. Azithromycin as the dihydrate, is a white or almost white powder with a molecular formula of C38H72N2O122H2O and a molecular weight of 785.02. Azithromycin tablets, USP are supplied for oral administration as pink modified capsule shaped, film-coated tablets containing azithromycin dihydrate equivalent to 500 mg azithromycin, USP and the following inactive ingredients: anhydrous dibasic calcium phosphate, croscarmellose sodium, D&C Red #30 Aluminum Lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide and triacetin. FDA approved dissolution specification differs from the USP dissolution specification.</Description>
</NDC>
<NDC>
<NDCCode>67046-1502-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1502-3) </PackageDescription>
<NDC11Code>67046-1502-03</NDC11Code>
<ProductNDC>67046-1502</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin Dihydrate</ProprietaryName>
<NonProprietaryName>Azithromycin Dihydrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250128</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208250</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>Azithromycin Tablets, USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2- ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranos yl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O122H2O and a molecular weight of 785.0. Azithromycin is supplied as tablets containing azithromycin dihydrate equivalent to 250 mg azithromycin and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Blue #1 aluminum lake and lecithin, FD&C Red #40 aluminum Lake, FD&C Yellow #6 aluminum Lake, macrogol/PEG, magnesium stearate, polyvinyl alcohol, pregelatinized starch, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>67046-1503-3</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (67046-1503-3) </PackageDescription>
<NDC11Code>67046-1503-03</NDC11Code>
<ProductNDC>67046-1503</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin Dihydrate</ProprietaryName>
<NonProprietaryName>Azithromycin Dihydrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250128</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065400</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azithromycin tablets are a macrolide antibacterial indicated for mild to moderate infections caused by designated, susceptible bacteria: 1 Mycobacterial Infections ( 1.2) .</IndicationAndUsage>
<Description>Azithromycin tablets USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name ( 2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3- C-methyl-3- O-methyl-α -L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β- D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38H 72N 2O 12, and its molecular weight is 749.0. Azithromycin has the following structural formula:. Azithromycin, as the dihydrate, is a white to almost white crystalline powder with a molecular formula of C 38H 72N 2O 122H 2O and a molecular weight of 785.02. Azithromycin tablets USP contain azithromycin dihydrate equivalent to 600 mg azithromycin. They also contain the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl methyl cellulose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide and triacetin. Organic Impurities Test Pending.</Description>
</NDC>
<NDC>
<NDCCode>67296-1942-2</NDCCode>
<PackageDescription>2 CARTON in 1 BOX (67296-1942-2) / 1 BLISTER PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>67296-1942-02</NDC11Code>
<ProductNDC>67296-1942</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin Dihydrate</ProprietaryName>
<NonProprietaryName>Azithromycin Dihydrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208249</ApplicationNumber>
<LabelerName>Redpharm Drug</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>Azithromycin Tablets, USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38H 72N 2O 12, and its molecular weight is 749.00. Azithromycin has the following structural formula:. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 12∙2H 2O and a molecular weight of 785.0. Azithromycin is supplied as tablets containing azithromycin dihydrate equivalent to 500 mg azithromycin and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Blue #1 aluminum lake and lecithin, FD&C Red #40 aluminum Lake, FD&C Yellow #6 aluminum Lake, macrogol/PEG, magnesium stearate, polyvinyl alcohol, pregelatinized starch, talc, and titanium dioxide.</Description>
</NDC>
</NDCList>