{
"NDC": [
{
"NDCCode": "71919-750-36",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (71919-750-36) > 300 TABLET in 1 BOTTLE, GLASS",
"NDC11Code": "71919-0750-36",
"ProductNDC": "71919-750",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calcarea Phosphorica",
"NonProprietaryName": "Tribasic Calcium Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180531",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "TRIBASIC CALCIUM PHOSPHATE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180531",
"SamplePackage": "N"
},
{
"NDCCode": "63981-750-36",
"PackageDescription": "2 BOTTLE, PLASTIC in 1 BOX (63981-750-36) > 360 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC",
"NDC11Code": "63981-0750-36",
"ProductNDC": "63981-750",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20180731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206999",
"LabelerName": "Costco Wholesale",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180731",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps . temporarily reduces fever."
},
{
"NDCCode": "71919-772-18",
"PackageDescription": "50 VIAL, GLASS in 1 KIT (71919-772-18) > 1 KIT in 1 VIAL, GLASS (71919-772-01) * 750 PELLET in 1 VIAL, GLASS (68428-028-01) * 750 PELLET in 1 VIAL, GLASS (68428-138-01) * 750 PELLET in 1 VIAL, GLASS (68428-080-01) * 750 PELLET in 1 VIAL, GLASS (68428-117-01) * 750 PELLET in 1 VIAL, GLASS (68428-097-01) * 350 PELLET in 1 VIAL, GLASS (71919-766-01) * 750 PELLET in 1 VIAL, GLASS (68428-085-01) * 350 PELLET in 1 VIAL, GLASS (71919-761-01) * 750 PELLET in 1 VIAL, GLASS (68428-072-01) * 350 PELLET in 1 VIAL, GLASS (71919-767-01) * 750 PELLET in 1 VIAL, GLASS (68428-092-01) * 750 PELLET in 1 VIAL, GLASS (68428-042-01) * 750 PELLET in 1 VIAL, GLASS (68428-133-01) * 750 PELLET in 1 VIAL, GLASS (68428-124-01) * 750 PELLET in 1 VIAL, GLASS (68428-115-01) * 350 PELLET in 1 VIAL, GLASS (71919-769-01) * 750 PELLET in 1 VIAL, GLASS (68428-047-01) * 750 PELLET in 1 VIAL, GLASS (68428-095-01) * 350 PELLET in 1 VIAL, GLASS (71919-771-01) * 750 PELLET in 1 VIAL, GLASS (68428-068-01) * 750 PELLET in 1 VIAL, GLASS (68428-147-01) * 750 PELLET in 1 VIAL, GLASS (68428-030-01) * 750 PELLET in 1 VIAL, GLASS (68428-078-01) * 750 PELLET in 1 VIAL, GLASS (68428-032-01) * 750 PELLET in 1 VIAL, GLASS (68428-067-01) * 750 PELLET in 1 VIAL, GLASS (68428-111-01) * 750 PELLET in 1 VIAL, GLASS (68428-055-01) * 750 PELLET in 1 VIAL, GLASS (68428-074-01) * 750 PELLET in 1 VIAL, GLASS (68428-123-01) * 750 PELLET in 1 VIAL, GLASS (68428-073-01) * 750 PELLET in 1 VIAL, GLASS (68428-065-01) * 750 PELLET in 1 VIAL, GLASS (68428-142-01) * 750 PELLET in 1 VIAL, GLASS (68428-102-01) * 750 PELLET in 1 VIAL, GLASS (68428-122-01) * 750 PELLET in 1 VIAL, GLASS (68428-118-01) * 750 PELLET in 1 VIAL, GLASS (68428-052-01) * 750 PELLET in 1 VIAL, GLASS (68428-146-01) * 750 PELLET in 1 VIAL, GLASS (68428-144-01) * 750 PELLET in 1 VIAL, GLASS (68428-125-01) * 350 PELLET in 1 VIAL, GLASS (71919-773-01) * 750 PELLET in 1 VIAL, GLASS (68428-075-01) * 750 PELLET in 1 VIAL, GLASS (68428-156-01) * 750 PELLET in 1 VIAL, GLASS (68428-061-01) * 750 PELLET in 1 VIAL, GLASS (68428-082-01) * 750 PELLET in 1 VIAL, GLASS (68428-127-01) * 750 PELLET in 1 VIAL, GLASS (68428-045-01) * 350 PELLET in 1 VIAL, GLASS (71919-760-01) * 750 PELLET in 1 VIAL, GLASS (68428-035-01) * 350 PELLET in 1 VIAL, GLASS (71919-759-01) * 750 PELLET in 1 VIAL, GLASS (68428-105-01) ",
"NDC11Code": "71919-0772-18",
"ProductNDC": "71919-772",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "30c And 200c Homeopathic Remedy Kit",
"NonProprietaryName": "50 Remedy Kit",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20220610",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220610",
"SamplePackage": "N",
"IndicationAndUsage": "Indications:. ACONITUM NAPELLUS Fear ALLIUM CEPA Head cold ANTIMONIUM TART Loose cough APIS MELLIFICA Stings ARGENTUM NITRICUM Impulsiveness ARNICA MONTANA Trauma ARSENICUM ALBUM Food poisoning BELLADONNA Fever BRYONIA ALBA Worse motion CALCAREA CARBONICA Overwork CALCAREA PHOSPHORICA Stiffness CALENDULA OFFICINALIS Wounds CANTHARIS Urinary tract CARBO VEGETABILIS Exhaustion CAULOPHYLLUM THAL Cramps CAUSTICUM Hoarseness CHAMOMILLA Irritability CINCHONA OFFICINALIS Debility COCCULUS INDICUS Motion sickness COFFEA CRUDA Sleeplessness COLOCYNTHIS Colic-like pain EUPHRASIA OFFICINALIS Eye irritation FERRUM PHOSPHORICUM Low fever GELSEMIUM SEMPERVIRENS Lethargy GLONOINUM Throbbing HEPAR SULPHURIS CALCAREUM Croupiness HYPERICUM PERFORATUM Shooting pain IGNATIA AMARA Sadness IPECACUANHA Nausea KALI BICHROMICUM Sinuses LACHESIS MUTUS Sore throat LEDUM PALUSTRE Black eyes LYCOPODIUM Digestion MAGNESIA PHOSPHORICA Cramps MERCURIUS VIVUS Sore throat NATRUM MURIATICUM Sneezing NUX VOMICA Vomiting PHOSPHORUS Hoarseness PHYTOLACCA Breast pain PULSATILLA Weeping PYROGENIUM Abscesses RHUS TOXICODENDRON Better motion RUTA GRAVEOLENS Bruised feeling SEPIA Indifference SILICEA Formation of pus SPONGIA TOSTA Wheezing STAPHYSAGRIA Anger SULFUR Skin problems SYMPHYTUM OFFICINALE Prickling pain THUJA OCCIDENTALIS Warts."
},
{
"NDCCode": "71919-798-01",
"PackageDescription": "750 PELLET in 1 VIAL, GLASS (71919-798-01) ",
"NDC11Code": "71919-0798-01",
"ProductNDC": "71919-798",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Camphora Kit Refill",
"NonProprietaryName": "Camphora",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230913",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CAMPHOR (NATURAL)",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230913",
"SamplePackage": "N",
"IndicationAndUsage": "Indications. CAMPHORA coldness."
},
{
"NDCCode": "71919-799-01",
"PackageDescription": "750 PELLET in 1 VIAL, GLASS (71919-799-01) ",
"NDC11Code": "71919-0799-01",
"ProductNDC": "71919-799",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Camphora Kit Refill",
"NonProprietaryName": "Camphora",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230914",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CAMPHOR (NATURAL)",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230914",
"SamplePackage": "N",
"IndicationAndUsage": "Indications. CAMPHORA coldness."
},
{
"NDCCode": "71919-812-01",
"PackageDescription": "750 PELLET in 1 VIAL, GLASS (71919-812-01) ",
"NDC11Code": "71919-0812-01",
"ProductNDC": "71919-812",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antimonium Crudum Kit Refill",
"NonProprietaryName": "Antimony Trisulfide",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231107",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ANTIMONY TRISULFIDE",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231107",
"SamplePackage": "N",
"IndicationAndUsage": "Indications:. ANTIMONIUM CRUDUM Warts."
},
{
"NDCCode": "71919-813-01",
"PackageDescription": "750 PELLET in 1 VIAL, GLASS (71919-813-01) ",
"NDC11Code": "71919-0813-01",
"ProductNDC": "71919-813",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kali Muriaticum Kit Refill",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231107",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231107",
"SamplePackage": "N",
"IndicationAndUsage": "Indications:. KALI MURIATICUM Congested ears."
},
{
"NDCCode": "71919-814-01",
"PackageDescription": "750 PELLET in 1 VIAL, GLASS (71919-814-01) ",
"NDC11Code": "71919-0814-01",
"ProductNDC": "71919-814",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Phosphoricum Acidum Kit Refill",
"NonProprietaryName": "Phosphoric Acid",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231107",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "PHOSPHORIC ACID",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231107",
"SamplePackage": "N",
"IndicationAndUsage": "Indications:. PHOSPHORICUM ACIDUM Headache."
},
{
"NDCCode": "71919-821-18",
"PackageDescription": "50 VIAL, GLASS in 1 KIT (71919-821-18) / 1 KIT in 1 VIAL, GLASS (71919-821-01) * 750 PELLET in 1 VIAL, GLASS (68428-127-01) * 750 PELLET in 1 VIAL, GLASS (68428-124-01) * 750 PELLET in 1 VIAL, GLASS (68428-123-01) * 750 PELLET in 1 VIAL, GLASS (68428-122-01) * 750 PELLET in 1 VIAL, GLASS (68428-119-01) * 750 PELLET in 1 VIAL, GLASS (68428-146-01) * 750 PELLET in 1 VIAL, GLASS (68428-099-01) * 750 PELLET in 1 VIAL, GLASS (68428-098-01) * 750 PELLET in 1 VIAL, GLASS (68428-097-01) * 750 PELLET in 1 VIAL, GLASS (68428-144-01) * 750 PELLET in 1 VIAL, GLASS (68428-142-01) * 750 PELLET in 1 VIAL, GLASS (68428-148-01) * 750 PELLET in 1 VIAL, GLASS (68428-147-01) * 750 PELLET in 1 VIAL, GLASS (68428-105-01) * 750 PELLET in 1 VIAL, GLASS (68428-104-01) * 750 PELLET in 1 VIAL, GLASS (68428-103-01) * 750 PELLET in 1 VIAL, GLASS (68428-102-01) * 350 PELLET in 1 VIAL, GLASS (71919-768-01) * 750 PELLET in 1 VIAL, GLASS (68428-101-01) * 750 PELLET in 1 VIAL, GLASS (68428-154-01) * 750 PELLET in 1 VIAL, GLASS (68428-112-01) * 750 PELLET in 1 VIAL, GLASS (68428-111-01) * 750 PELLET in 1 VIAL, GLASS (68428-109-01) * 750 PELLET in 1 VIAL, GLASS (68428-108-01) * 750 PELLET in 1 VIAL, GLASS (68428-107-01) * 750 PELLET in 1 VIAL, GLASS (68428-106-01) * 750 PELLET in 1 VIAL, GLASS (68428-149-01) * 750 PELLET in 1 VIAL, GLASS (68428-118-01) * 750 PELLET in 1 VIAL, GLASS (68428-117-01) * 750 PELLET in 1 VIAL, GLASS (68428-115-01) * 750 PELLET in 1 VIAL, GLASS (68428-156-01) * 750 PELLET in 1 VIAL, GLASS (68428-114-01) * 750 PELLET in 1 VIAL, GLASS (68428-155-01) * 750 PELLET in 1 VIAL, GLASS (68428-086-01) * 750 PELLET in 1 VIAL, GLASS (68428-095-01) * 750 PELLET in 1 VIAL, GLASS (68428-138-01) * 750 PELLET in 1 VIAL, GLASS (68428-092-01) * 750 PELLET in 1 VIAL, GLASS (68428-091-01) * 750 PELLET in 1 VIAL, GLASS (68428-085-01) * 750 PELLET in 1 VIAL, GLASS (68428-090-01) * 750 PELLET in 1 VIAL, GLASS (68428-134-01) * 750 PELLET in 1 VIAL, GLASS (68428-133-01) * 750 PELLET in 1 VIAL, GLASS (68428-084-01) * 750 PELLET in 1 VIAL, GLASS (68428-083-01) * 750 PELLET in 1 VIAL, GLASS (68428-082-01) * 750 PELLET in 1 VIAL, GLASS (68428-080-01) * 750 PELLET in 1 VIAL, GLASS (68428-131-01) * 750 PELLET in 1 VIAL, GLASS (68428-078-01) * 750 PELLET in 1 VIAL, GLASS (68428-125-01) * 750 PELLET in 1 VIAL, GLASS (68428-077-01) ",
"NDC11Code": "71919-0821-18",
"ProductNDC": "71919-821",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "30c Homeopathic Remedy Kit",
"NonProprietaryName": "50 Remedy Kit",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20240221",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240221",
"SamplePackage": "N",
"IndicationAndUsage": "Acon nap fear. Aesculus hipp hemorrhoids. Allium cepa head cold. Antimon crud warts. Apis mel stings. Arnica bruises. Arsenicum alb vomiting. Belladonna fever. Bellis bruised soreness. Berber vulg itching. Bryonia worse motion. Calc carb overwork. Caulophyllum cramps. Causticum hoarseness. Chamomilla irritability. Cimicifuga minor back pain. Coffea cruda sleeplessness. Drosera cough. Eupatorium perf flu-like symptoms. Euphrasia eye irritation. Ferrum phos low fever. Gelsemium lethargy. Hamamelis varicose veins. Hepar sulph calc croupiness. Hydrastis sinuses. Hypericum shooting pain. Ignatia sadness. Ipecac nausea. Kali bic sinuses. Kali carb sour belching. Kali mur congested ears. Kali phos irritability. Lachesis sore throat. Ledum black eyes. Lycopodium digestion. Mag phos cramps. Nat mur sneezing. Nux vom vomiting. Petroleum nausea. Phosphoricum ac headache. Phytolacca sore throat. Podoph pelt diarrhea. Pulsatilla weeping. Rhus tox better motion. Ruta bruised feeling. Sepia indifference. Staphysag anger. Sulphur skin problems. Symphytum prickling pain. Thuja occ warts."
},
{
"NDCCode": "71919-822-18",
"PackageDescription": "50 VIAL, GLASS in 1 KIT (71919-822-18) / 1 KIT in 1 VIAL, GLASS (71919-822-01) * 350 PELLET in 1 VIAL, GLASS (71919-759-01) * 750 PELLET in 1 VIAL, GLASS (68428-074-01) * 750 PELLET in 1 VIAL, GLASS (68428-072-01) * 750 PELLET in 1 VIAL, GLASS (68428-069-01) * 750 PELLET in 1 VIAL, GLASS (68428-068-01) * 750 PELLET in 1 VIAL, GLASS (68428-067-01) * 750 PELLET in 1 VIAL, GLASS (68428-073-01) * 750 PELLET in 1 VIAL, GLASS (68428-065-01) * 350 PELLET in 1 VIAL, GLASS (71919-771-01) * 750 PELLET in 1 VIAL, GLASS (68428-064-01) * 750 PELLET in 1 VIAL, GLASS (71919-814-01) * 350 PELLET in 1 VIAL, GLASS (71919-770-01) * 750 PELLET in 1 VIAL, GLASS (68428-062-01) * 750 PELLET in 1 VIAL, GLASS (68428-061-01) * 750 PELLET in 1 VIAL, GLASS (68428-059-01) * 750 PELLET in 1 VIAL, GLASS (68428-058-01) * 750 PELLET in 1 VIAL, GLASS (68428-057-01) * 750 PELLET in 1 VIAL, GLASS (68428-056-01) * 350 PELLET in 1 VIAL, GLASS (71919-777-01) * 750 PELLET in 1 VIAL, GLASS (71919-813-01) * 350 PELLET in 1 VIAL, GLASS (71919-769-01) * 750 PELLET in 1 VIAL, GLASS (68428-055-01) * 750 PELLET in 1 VIAL, GLASS (68428-053-01) * 750 PELLET in 1 VIAL, GLASS (68428-054-01) * 750 PELLET in 1 VIAL, GLASS (68428-052-01) * 350 PELLET in 1 VIAL, GLASS (71919-763-01) * 750 PELLET in 1 VIAL, GLASS (68428-051-01) * 350 PELLET in 1 VIAL, GLASS (71919-760-01) * 750 PELLET in 1 VIAL, GLASS (68428-049-01) * 750 PELLET in 1 VIAL, GLASS (68428-048-01) * 750 PELLET in 1 VIAL, GLASS (68428-047-01) * 350 PELLET in 1 VIAL, GLASS (71919-766-01) * 350 PELLET in 1 VIAL, GLASS (71919-761-01) * 750 PELLET in 1 VIAL, GLASS (68428-045-01) * 350 PELLET in 1 VIAL, GLASS (71919-767-01) * 750 PELLET in 1 VIAL, GLASS (68428-042-01) * 750 PELLET in 1 VIAL, GLASS (68428-041-01) * 750 PELLET in 1 VIAL, GLASS (68428-036-01) * 750 PELLET in 1 VIAL, GLASS (68428-035-01) * 350 PELLET in 1 VIAL, GLASS (71919-762-01) * 350 PELLET in 1 VIAL, GLASS (71919-773-01) * 750 PELLET in 1 VIAL, GLASS (68428-034-01) * 750 PELLET in 1 VIAL, GLASS (68428-040-01) * 750 PELLET in 1 VIAL, GLASS (68428-033-01) * 750 PELLET in 1 VIAL, GLASS (68428-032-01) * 750 PELLET in 1 VIAL, GLASS (68428-030-01) * 750 PELLET in 1 VIAL, GLASS (71919-812-01) * 750 PELLET in 1 VIAL, GLASS (68428-028-01) * 750 PELLET in 1 VIAL, GLASS (68428-075-01) * 750 PELLET in 1 VIAL, GLASS (68428-026-01) ",
"NDC11Code": "71919-0822-18",
"ProductNDC": "71919-822",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "200c Homeopathic Remedy Kit",
"NonProprietaryName": "50 Remedy Kit",
"DosageFormName": "KIT",
"StartMarketingDate": "20240229",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240229",
"SamplePackage": "N",
"IndicationAndUsage": "Acon nap fear. Aesculus hipp hemorrhoids. Allium cepa head cold. Antimon crud warts. Apis mel stings. Arnica bruises. Arsenicum alb vomiting. Belladonna fever. Bellis bruised soreness. Berber vulg itching. Bryonia worse motion. Calc carb overwork. Caulophyllum cramps. Causticum hoarseness. Chamomilla irritability. Cimicifuga minor back pain. Coffea cruda sleeplessness. Drosera cough. Eupatorium perf flu-like symptoms. Euphrasia eye irritation. Ferrum phos low fever. Gelsemium lethargy. Hamamelis varicose veins. Hepar sulph calc croupiness. Hydrastis sinuses. Hypericum shooting pain. Ignatia sadness. Ipecac nausea. Kali bic sinuses. Kali carb sour belching. Kali mur congested ears. Kali phos irritability. Lachesis sore throat. Ledum black eyes. Lycopodium digestion. Mag phos cramps. Nat mur sneezing. Nux vom vomiting. Petroleum nausea. Phosphoricum ac headache. Phytolacca sore throat. Podoph pelt diarrhea. Pulsatilla weeping. Rhus tox better motion. Ruta bruised feeling. Sepia indifference. Staphysag anger. Sulphur skin problems. Symphytum prickling pain. Thuja occ warts."
},
{
"NDCCode": "71919-741-36",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (71919-741-36) > 300 TABLET in 1 BOTTLE, GLASS",
"NDC11Code": "71919-0741-36",
"ProductNDC": "71919-741",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Natrum Phosphoricum",
"NonProprietaryName": "Sodium Phosphate, Dibasic, Heptahydrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180531",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180531",
"SamplePackage": "N"
},
{
"NDCCode": "71919-742-36",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (71919-742-36) > 300 TABLET in 1 BOTTLE, GLASS",
"NDC11Code": "71919-0742-36",
"ProductNDC": "71919-742",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Natrum Sulphuricum",
"NonProprietaryName": "Sodium Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180531",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "SODIUM SULFATE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180531",
"SamplePackage": "N"
},
{
"NDCCode": "71919-743-36",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (71919-743-36) > 300 TABLET in 1 BOTTLE, GLASS",
"NDC11Code": "71919-0743-36",
"ProductNDC": "71919-743",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Natrum Muriaticum",
"NonProprietaryName": "Sodium Chloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180531",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "SODIUM CHLORIDE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180531",
"SamplePackage": "N"
},
{
"NDCCode": "71919-744-36",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (71919-744-36) > 300 TABLET in 1 BOTTLE, GLASS",
"NDC11Code": "71919-0744-36",
"ProductNDC": "71919-744",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Magnesia Phosphorica",
"NonProprietaryName": "Magnesium Phosphate, Dibasic Trihydrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180531",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180531",
"SamplePackage": "N"
},
{
"NDCCode": "71919-745-36",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (71919-745-36) > 300 TABLET in 1 BOTTLE, GLASS",
"NDC11Code": "71919-0745-36",
"ProductNDC": "71919-745",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kali Sulphuricum",
"NonProprietaryName": "Potassium Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180531",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "POTASSIUM SULFATE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180531",
"SamplePackage": "N"
},
{
"NDCCode": "71919-746-36",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (71919-746-36) > 300 TABLET in 1 BOTTLE, GLASS",
"NDC11Code": "71919-0746-36",
"ProductNDC": "71919-746",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kali Phosphoricum",
"NonProprietaryName": "Dibasic Potassium Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180531",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "DIBASIC POTASSIUM PHOSPHATE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180531",
"SamplePackage": "N"
},
{
"NDCCode": "71919-747-36",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (71919-747-36) > 300 TABLET in 1 BOTTLE, GLASS",
"NDC11Code": "71919-0747-36",
"ProductNDC": "71919-747",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kali Muriaticum",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180531",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180531",
"SamplePackage": "N"
},
{
"NDCCode": "71919-748-36",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (71919-748-36) > 300 TABLET in 1 BOTTLE, GLASS",
"NDC11Code": "71919-0748-36",
"ProductNDC": "71919-748",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ferrum Phosphoricum",
"NonProprietaryName": "Ferrosoferric Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180531",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "FERROSOFERRIC PHOSPHATE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180531",
"SamplePackage": "N"
},
{
"NDCCode": "71919-749-36",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (71919-749-36) > 300 TABLET in 1 BOTTLE, GLASS",
"NDC11Code": "71919-0749-36",
"ProductNDC": "71919-749",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calcarea Fluorica",
"NonProprietaryName": "Calcium Fluoride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180531",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CALCIUM FLUORIDE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180531",
"SamplePackage": "N"
},
{
"NDCCode": "71919-751-36",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (71919-751-36) > 300 TABLET in 1 BOTTLE, GLASS",
"NDC11Code": "71919-0751-36",
"ProductNDC": "71919-751",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calcarea Sulphurica",
"NonProprietaryName": "Calcium Sulfate Anhydrous",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180531",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CALCIUM SULFATE ANHYDROUS",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180531",
"SamplePackage": "N"
},
{
"NDCCode": "71919-752-36",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (71919-752-36) > 300 TABLET in 1 BOTTLE, GLASS",
"NDC11Code": "71919-0752-36",
"ProductNDC": "71919-752",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Silicea",
"NonProprietaryName": "Silicon Dioxide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180531",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "SILICON DIOXIDE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180531",
"SamplePackage": "N"
},
{
"NDCCode": "71919-753-36",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (71919-753-36) > 300 TABLET in 1 BOTTLE, GLASS",
"NDC11Code": "71919-0753-36",
"ProductNDC": "71919-753",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cell Salts Combination",
"NonProprietaryName": "Calcium Fluoride, Tribasic Calcium Phosphate, Calcium Sulfate Anhydrous, Ferrosoferric Phosphate, Potassium Chloride, Dibasic Potassium Phosphate, Potassium Sulfate, Magnesium Phosphate, Dibasic Trihydrate, Sodium Chloride, Sodium Phosphate, Dibasic, Heptahydrate, Sodium Sulfate, Silicon Dioxide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180531",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "TRIBASIC CALCIUM PHOSPHATE; CALCIUM SULFATE ANHYDROUS; FERROSOFERRIC PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE; POTASSIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; CALCIUM FLUORIDE; SILICON DIOXIDE; POTASSIUM CHLORIDE",
"StrengthNumber": "6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180531",
"SamplePackage": "N"
},
{
"NDCCode": "0135-0469-01",
"PackageDescription": "36 TABLET, CHEWABLE in 1 BOTTLE (0135-0469-01)",
"NDC11Code": "00135-0469-01",
"ProductNDC": "0135-0469",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tums",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20100407",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part331",
"LabelerName": "GlaxoSmithKline Consumer Healthcare Holdings (US) LLC",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0143-9161-10",
"PackageDescription": "10 VIAL in 1 PACKAGE (0143-9161-10) / 513 mg in 1 VIAL (0143-9161-01) ",
"NDC11Code": "00143-9161-10",
"ProductNDC": "0143-9161",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS; ORAL",
"StartMarketingDate": "20230202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210274",
"LabelerName": "HIKMA PHARMACEUTICALS USA INC.",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "513",
"StrengthUnit": "mg/mg",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2025-08-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241203",
"SamplePackage": "N",
"Description": "Vancomycin Hydrochloride for Injection contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[l,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. Vancomycin Hydrochloride for Injection is a sterile, preservative-free, white, almost white to tan to brown, spray-dried powder, for preparing intravenous (IV) infusions, in single-dose vials each containing the equivalent of 500 mg, 750 mg, 1 g, 1.25 g or 1.5 g vancomycin base. Each 500 mg vial contains 500 mg vancomycin (equivalent to 513 mg vancomycin hydrochloride), 125 mg trehalose, 0.05 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 750 mg vial contains 750 mg vancomycin (equivalent to 769 mg vancomycin hydrochloride), 187.5 mg trehalose, 0.075 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1 g vial contains 1 g vancomycin (equivalent to 1.025 g vancomycin hydrochloride), 250 mg trehalose, 0.1 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.25 g vial contains 1.25 g vancomycin (equivalent to 1.28 g vancomycin hydrochloride), 312.5 mg trehalose, 0.125 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.5 g vial contains 1.5 g vancomycin (equivalent to 1.54 g vancomycin hydrochloride), 375 mg trehalose, 0.15 mg polysorbate 80, and hydrochloric acid used to adjust the pH. The spray-dried powder is reconstituted with Sterile Water for Injection which forms a clear solution and subsequently diluted prior to intravenous or oral administration [see Dosage and Administration (2.5, 2.8)]. Vancomycin Hydrochloride for Injection may also be diluted with a sweetening agent for oral administration [see Dosage and Administration (2.8)]."
},
{
"NDCCode": "0143-9161-25",
"PackageDescription": "25 VIAL in 1 PACKAGE (0143-9161-25) / 513 mg in 1 VIAL (0143-9161-01) ",
"NDC11Code": "00143-9161-25",
"ProductNDC": "0143-9161",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS; ORAL",
"StartMarketingDate": "20230202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210274",
"LabelerName": "HIKMA PHARMACEUTICALS USA INC.",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "513",
"StrengthUnit": "mg/mg",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2025-08-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230202",
"SamplePackage": "N",
"Description": "Vancomycin Hydrochloride for Injection contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[l,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. Vancomycin Hydrochloride for Injection is a sterile, preservative-free, white, almost white to tan to brown, spray-dried powder, for preparing intravenous (IV) infusions, in single-dose vials each containing the equivalent of 500 mg, 750 mg, 1 g, 1.25 g or 1.5 g vancomycin base. Each 500 mg vial contains 500 mg vancomycin (equivalent to 513 mg vancomycin hydrochloride), 125 mg trehalose, 0.05 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 750 mg vial contains 750 mg vancomycin (equivalent to 769 mg vancomycin hydrochloride), 187.5 mg trehalose, 0.075 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1 g vial contains 1 g vancomycin (equivalent to 1.025 g vancomycin hydrochloride), 250 mg trehalose, 0.1 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.25 g vial contains 1.25 g vancomycin (equivalent to 1.28 g vancomycin hydrochloride), 312.5 mg trehalose, 0.125 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.5 g vial contains 1.5 g vancomycin (equivalent to 1.54 g vancomycin hydrochloride), 375 mg trehalose, 0.15 mg polysorbate 80, and hydrochloric acid used to adjust the pH. The spray-dried powder is reconstituted with Sterile Water for Injection which forms a clear solution and subsequently diluted prior to intravenous or oral administration [see Dosage and Administration (2.5, 2.8)]. Vancomycin Hydrochloride for Injection may also be diluted with a sweetening agent for oral administration [see Dosage and Administration (2.8)]."
},
{
"NDCCode": "0143-9162-10",
"PackageDescription": "10 VIAL in 1 PACKAGE (0143-9162-10) / 1025 mg in 1 VIAL (0143-9162-01) ",
"NDC11Code": "00143-9162-10",
"ProductNDC": "0143-9162",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS; ORAL",
"StartMarketingDate": "20230202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210274",
"LabelerName": "HIKMA PHARMACEUTICALS USA INC.",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "1025",
"StrengthUnit": "mg/mg",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2025-08-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230202",
"SamplePackage": "N",
"Description": "Vancomycin Hydrochloride for Injection contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[l,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. Vancomycin Hydrochloride for Injection is a sterile, preservative-free, white, almost white to tan to brown, spray-dried powder, for preparing intravenous (IV) infusions, in single-dose vials each containing the equivalent of 500 mg, 750 mg, 1 g, 1.25 g or 1.5 g vancomycin base. Each 500 mg vial contains 500 mg vancomycin (equivalent to 513 mg vancomycin hydrochloride), 125 mg trehalose, 0.05 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 750 mg vial contains 750 mg vancomycin (equivalent to 769 mg vancomycin hydrochloride), 187.5 mg trehalose, 0.075 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1 g vial contains 1 g vancomycin (equivalent to 1.025 g vancomycin hydrochloride), 250 mg trehalose, 0.1 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.25 g vial contains 1.25 g vancomycin (equivalent to 1.28 g vancomycin hydrochloride), 312.5 mg trehalose, 0.125 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.5 g vial contains 1.5 g vancomycin (equivalent to 1.54 g vancomycin hydrochloride), 375 mg trehalose, 0.15 mg polysorbate 80, and hydrochloric acid used to adjust the pH. The spray-dried powder is reconstituted with Sterile Water for Injection which forms a clear solution and subsequently diluted prior to intravenous or oral administration [see Dosage and Administration (2.5, 2.8)]. Vancomycin Hydrochloride for Injection may also be diluted with a sweetening agent for oral administration [see Dosage and Administration (2.8)]."
},
{
"NDCCode": "0143-9355-10",
"PackageDescription": "10 VIAL in 1 CARTON (0143-9355-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0143-9355-01) ",
"NDC11Code": "00143-9355-10",
"ProductNDC": "0143-9355",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20181003",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206616",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "VANCOMYCIN",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2022-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
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"IndicationAndUsage": "Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin Hydrochloride for Injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.",
"Description": "Vancomycin Hydrochloride for Injection, USP is a lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 750 mg vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL, the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopasis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S-[3R*,6S*(S*),7S*,22S*,23R*,26R*,36S*,38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula."
},
{
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"PackageDescription": "6 BAG in 1 CARTON (0143-9466-06) / 250 mL in 1 BAG (0143-9466-01) ",
"NDC11Code": "00143-9466-06",
"ProductNDC": "0143-9466",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tyzavan",
"NonProprietaryName": "Vancomycin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251017",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211962",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "VANCOMYCIN",
"StrengthNumber": "1.25",
"StrengthUnit": "g/250mL",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-08-25",
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"IndicationAndUsage": "TYZAVAN is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients (1 month and older) for whom appropriate dosing with this formulation can be achieved: : 1 Septicemia (1.1), 2 Infective Endocarditis (1.2), 3 Skin and Skin Structure Infections (1.3), 4 Bone Infections (1.4), 5 Lower Respiratory Tract Infections (1.5).",
"Description": "TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags contain vancomycin as vancomycin hydrochloride. It is a tricyclic glycopeptide antibacterial drug derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-{[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]-oxy}-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino]valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36(iminometha-no)-13,16:31,35-dimetheno-1H,16H-[1,6,9]-oxadiazacyclohexadecino-[4,5-m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags are sterile, nonpyrogenic premixed 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL or 400 mL solution containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g vancomycin, respectively, as vancomycin hydrochloride. Each 100 mL of solution contains 1.36 g N-acetyl-D-alanine, 1.26 g L-lysine hydrochloride (monochloride) in water for injection. Hydrochloric acid and sodium hydroxide are used for pH adjustment. The pH is 4.5 to 5.5 and the osmolarity is 350 to 475 mOsmol/L."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Hikma Pharmaceuticals USA Inc.",
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"IndicationAndUsage": "TYZAVAN is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients (1 month and older) for whom appropriate dosing with this formulation can be achieved: : 1 Septicemia (1.1), 2 Infective Endocarditis (1.2), 3 Skin and Skin Structure Infections (1.3), 4 Bone Infections (1.4), 5 Lower Respiratory Tract Infections (1.5).",
"Description": "TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags contain vancomycin as vancomycin hydrochloride. It is a tricyclic glycopeptide antibacterial drug derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-{[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]-oxy}-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino]valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36(iminometha-no)-13,16:31,35-dimetheno-1H,16H-[1,6,9]-oxadiazacyclohexadecino-[4,5-m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags are sterile, nonpyrogenic premixed 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL or 400 mL solution containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g vancomycin, respectively, as vancomycin hydrochloride. Each 100 mL of solution contains 1.36 g N-acetyl-D-alanine, 1.26 g L-lysine hydrochloride (monochloride) in water for injection. Hydrochloric acid and sodium hydroxide are used for pH adjustment. The pH is 4.5 to 5.5 and the osmolarity is 350 to 475 mOsmol/L."
},
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "TYZAVAN is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients (1 month and older) for whom appropriate dosing with this formulation can be achieved: : 1 Septicemia (1.1), 2 Infective Endocarditis (1.2), 3 Skin and Skin Structure Infections (1.3), 4 Bone Infections (1.4), 5 Lower Respiratory Tract Infections (1.5).",
"Description": "TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags contain vancomycin as vancomycin hydrochloride. It is a tricyclic glycopeptide antibacterial drug derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-{[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]-oxy}-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino]valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36(iminometha-no)-13,16:31,35-dimetheno-1H,16H-[1,6,9]-oxadiazacyclohexadecino-[4,5-m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags are sterile, nonpyrogenic premixed 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL or 400 mL solution containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g vancomycin, respectively, as vancomycin hydrochloride. Each 100 mL of solution contains 1.36 g N-acetyl-D-alanine, 1.26 g L-lysine hydrochloride (monochloride) in water for injection. Hydrochloric acid and sodium hydroxide are used for pH adjustment. The pH is 4.5 to 5.5 and the osmolarity is 350 to 475 mOsmol/L."
}
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<ProprietaryName>Antimonium Crudum Kit Refill</ProprietaryName>
<NonProprietaryName>Antimony Trisulfide</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231107</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>ANTIMONY TRISULFIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications:. ANTIMONIUM CRUDUM Warts.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71919-813-01</NDCCode>
<PackageDescription>750 PELLET in 1 VIAL, GLASS (71919-813-01) </PackageDescription>
<NDC11Code>71919-0813-01</NDC11Code>
<ProductNDC>71919-813</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kali Muriaticum Kit Refill</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231107</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications:. KALI MURIATICUM Congested ears.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71919-814-01</NDCCode>
<PackageDescription>750 PELLET in 1 VIAL, GLASS (71919-814-01) </PackageDescription>
<NDC11Code>71919-0814-01</NDC11Code>
<ProductNDC>71919-814</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Phosphoricum Acidum Kit Refill</ProprietaryName>
<NonProprietaryName>Phosphoric Acid</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231107</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>PHOSPHORIC ACID</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications:. PHOSPHORICUM ACIDUM Headache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71919-821-18</NDCCode>
<PackageDescription>50 VIAL, GLASS in 1 KIT (71919-821-18) / 1 KIT in 1 VIAL, GLASS (71919-821-01) * 750 PELLET in 1 VIAL, GLASS (68428-127-01) * 750 PELLET in 1 VIAL, GLASS (68428-124-01) * 750 PELLET in 1 VIAL, GLASS (68428-123-01) * 750 PELLET in 1 VIAL, GLASS (68428-122-01) * 750 PELLET in 1 VIAL, GLASS (68428-119-01) * 750 PELLET in 1 VIAL, GLASS (68428-146-01) * 750 PELLET in 1 VIAL, GLASS (68428-099-01) * 750 PELLET in 1 VIAL, GLASS (68428-098-01) * 750 PELLET in 1 VIAL, GLASS (68428-097-01) * 750 PELLET in 1 VIAL, GLASS (68428-144-01) * 750 PELLET in 1 VIAL, GLASS (68428-142-01) * 750 PELLET in 1 VIAL, GLASS (68428-148-01) * 750 PELLET in 1 VIAL, GLASS (68428-147-01) * 750 PELLET in 1 VIAL, GLASS (68428-105-01) * 750 PELLET in 1 VIAL, GLASS (68428-104-01) * 750 PELLET in 1 VIAL, GLASS (68428-103-01) * 750 PELLET in 1 VIAL, GLASS (68428-102-01) * 350 PELLET in 1 VIAL, GLASS (71919-768-01) * 750 PELLET in 1 VIAL, GLASS (68428-101-01) * 750 PELLET in 1 VIAL, GLASS (68428-154-01) * 750 PELLET in 1 VIAL, GLASS (68428-112-01) * 750 PELLET in 1 VIAL, GLASS (68428-111-01) * 750 PELLET in 1 VIAL, GLASS (68428-109-01) * 750 PELLET in 1 VIAL, GLASS (68428-108-01) * 750 PELLET in 1 VIAL, GLASS (68428-107-01) * 750 PELLET in 1 VIAL, GLASS (68428-106-01) * 750 PELLET in 1 VIAL, GLASS (68428-149-01) * 750 PELLET in 1 VIAL, GLASS (68428-118-01) * 750 PELLET in 1 VIAL, GLASS (68428-117-01) * 750 PELLET in 1 VIAL, GLASS (68428-115-01) * 750 PELLET in 1 VIAL, GLASS (68428-156-01) * 750 PELLET in 1 VIAL, GLASS (68428-114-01) * 750 PELLET in 1 VIAL, GLASS (68428-155-01) * 750 PELLET in 1 VIAL, GLASS (68428-086-01) * 750 PELLET in 1 VIAL, GLASS (68428-095-01) * 750 PELLET in 1 VIAL, GLASS (68428-138-01) * 750 PELLET in 1 VIAL, GLASS (68428-092-01) * 750 PELLET in 1 VIAL, GLASS (68428-091-01) * 750 PELLET in 1 VIAL, GLASS (68428-085-01) * 750 PELLET in 1 VIAL, GLASS (68428-090-01) * 750 PELLET in 1 VIAL, GLASS (68428-134-01) * 750 PELLET in 1 VIAL, GLASS (68428-133-01) * 750 PELLET in 1 VIAL, GLASS (68428-084-01) * 750 PELLET in 1 VIAL, GLASS (68428-083-01) * 750 PELLET in 1 VIAL, GLASS (68428-082-01) * 750 PELLET in 1 VIAL, GLASS (68428-080-01) * 750 PELLET in 1 VIAL, GLASS (68428-131-01) * 750 PELLET in 1 VIAL, GLASS (68428-078-01) * 750 PELLET in 1 VIAL, GLASS (68428-125-01) * 750 PELLET in 1 VIAL, GLASS (68428-077-01) </PackageDescription>
<NDC11Code>71919-0821-18</NDC11Code>
<ProductNDC>71919-821</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>30c Homeopathic Remedy Kit</ProprietaryName>
<NonProprietaryName>50 Remedy Kit</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240221</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acon nap fear. Aesculus hipp hemorrhoids. Allium cepa head cold. Antimon crud warts. Apis mel stings. Arnica bruises. Arsenicum alb vomiting. Belladonna fever. Bellis bruised soreness. Berber vulg itching. Bryonia worse motion. Calc carb overwork. Caulophyllum cramps. Causticum hoarseness. Chamomilla irritability. Cimicifuga minor back pain. Coffea cruda sleeplessness. Drosera cough. Eupatorium perf flu-like symptoms. Euphrasia eye irritation. Ferrum phos low fever. Gelsemium lethargy. Hamamelis varicose veins. Hepar sulph calc croupiness. Hydrastis sinuses. Hypericum shooting pain. Ignatia sadness. Ipecac nausea. Kali bic sinuses. Kali carb sour belching. Kali mur congested ears. Kali phos irritability. Lachesis sore throat. Ledum black eyes. Lycopodium digestion. Mag phos cramps. Nat mur sneezing. Nux vom vomiting. Petroleum nausea. Phosphoricum ac headache. Phytolacca sore throat. Podoph pelt diarrhea. Pulsatilla weeping. Rhus tox better motion. Ruta bruised feeling. Sepia indifference. Staphysag anger. Sulphur skin problems. Symphytum prickling pain. Thuja occ warts.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71919-822-18</NDCCode>
<PackageDescription>50 VIAL, GLASS in 1 KIT (71919-822-18) / 1 KIT in 1 VIAL, GLASS (71919-822-01) * 350 PELLET in 1 VIAL, GLASS (71919-759-01) * 750 PELLET in 1 VIAL, GLASS (68428-074-01) * 750 PELLET in 1 VIAL, GLASS (68428-072-01) * 750 PELLET in 1 VIAL, GLASS (68428-069-01) * 750 PELLET in 1 VIAL, GLASS (68428-068-01) * 750 PELLET in 1 VIAL, GLASS (68428-067-01) * 750 PELLET in 1 VIAL, GLASS (68428-073-01) * 750 PELLET in 1 VIAL, GLASS (68428-065-01) * 350 PELLET in 1 VIAL, GLASS (71919-771-01) * 750 PELLET in 1 VIAL, GLASS (68428-064-01) * 750 PELLET in 1 VIAL, GLASS (71919-814-01) * 350 PELLET in 1 VIAL, GLASS (71919-770-01) * 750 PELLET in 1 VIAL, GLASS (68428-062-01) * 750 PELLET in 1 VIAL, GLASS (68428-061-01) * 750 PELLET in 1 VIAL, GLASS (68428-059-01) * 750 PELLET in 1 VIAL, GLASS (68428-058-01) * 750 PELLET in 1 VIAL, GLASS (68428-057-01) * 750 PELLET in 1 VIAL, GLASS (68428-056-01) * 350 PELLET in 1 VIAL, GLASS (71919-777-01) * 750 PELLET in 1 VIAL, GLASS (71919-813-01) * 350 PELLET in 1 VIAL, GLASS (71919-769-01) * 750 PELLET in 1 VIAL, GLASS (68428-055-01) * 750 PELLET in 1 VIAL, GLASS (68428-053-01) * 750 PELLET in 1 VIAL, GLASS (68428-054-01) * 750 PELLET in 1 VIAL, GLASS (68428-052-01) * 350 PELLET in 1 VIAL, GLASS (71919-763-01) * 750 PELLET in 1 VIAL, GLASS (68428-051-01) * 350 PELLET in 1 VIAL, GLASS (71919-760-01) * 750 PELLET in 1 VIAL, GLASS (68428-049-01) * 750 PELLET in 1 VIAL, GLASS (68428-048-01) * 750 PELLET in 1 VIAL, GLASS (68428-047-01) * 350 PELLET in 1 VIAL, GLASS (71919-766-01) * 350 PELLET in 1 VIAL, GLASS (71919-761-01) * 750 PELLET in 1 VIAL, GLASS (68428-045-01) * 350 PELLET in 1 VIAL, GLASS (71919-767-01) * 750 PELLET in 1 VIAL, GLASS (68428-042-01) * 750 PELLET in 1 VIAL, GLASS (68428-041-01) * 750 PELLET in 1 VIAL, GLASS (68428-036-01) * 750 PELLET in 1 VIAL, GLASS (68428-035-01) * 350 PELLET in 1 VIAL, GLASS (71919-762-01) * 350 PELLET in 1 VIAL, GLASS (71919-773-01) * 750 PELLET in 1 VIAL, GLASS (68428-034-01) * 750 PELLET in 1 VIAL, GLASS (68428-040-01) * 750 PELLET in 1 VIAL, GLASS (68428-033-01) * 750 PELLET in 1 VIAL, GLASS (68428-032-01) * 750 PELLET in 1 VIAL, GLASS (68428-030-01) * 750 PELLET in 1 VIAL, GLASS (71919-812-01) * 750 PELLET in 1 VIAL, GLASS (68428-028-01) * 750 PELLET in 1 VIAL, GLASS (68428-075-01) * 750 PELLET in 1 VIAL, GLASS (68428-026-01) </PackageDescription>
<NDC11Code>71919-0822-18</NDC11Code>
<ProductNDC>71919-822</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>200c Homeopathic Remedy Kit</ProprietaryName>
<NonProprietaryName>50 Remedy Kit</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20240229</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acon nap fear. Aesculus hipp hemorrhoids. Allium cepa head cold. Antimon crud warts. Apis mel stings. Arnica bruises. Arsenicum alb vomiting. Belladonna fever. Bellis bruised soreness. Berber vulg itching. Bryonia worse motion. Calc carb overwork. Caulophyllum cramps. Causticum hoarseness. Chamomilla irritability. Cimicifuga minor back pain. Coffea cruda sleeplessness. Drosera cough. Eupatorium perf flu-like symptoms. Euphrasia eye irritation. Ferrum phos low fever. Gelsemium lethargy. Hamamelis varicose veins. Hepar sulph calc croupiness. Hydrastis sinuses. Hypericum shooting pain. Ignatia sadness. Ipecac nausea. Kali bic sinuses. Kali carb sour belching. Kali mur congested ears. Kali phos irritability. Lachesis sore throat. Ledum black eyes. Lycopodium digestion. Mag phos cramps. Nat mur sneezing. Nux vom vomiting. Petroleum nausea. Phosphoricum ac headache. Phytolacca sore throat. Podoph pelt diarrhea. Pulsatilla weeping. Rhus tox better motion. Ruta bruised feeling. Sepia indifference. Staphysag anger. Sulphur skin problems. Symphytum prickling pain. Thuja occ warts.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71919-741-36</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (71919-741-36) > 300 TABLET in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>71919-0741-36</NDC11Code>
<ProductNDC>71919-741</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Natrum Phosphoricum</ProprietaryName>
<NonProprietaryName>Sodium Phosphate, Dibasic, Heptahydrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180531</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71919-742-36</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (71919-742-36) > 300 TABLET in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>71919-0742-36</NDC11Code>
<ProductNDC>71919-742</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Natrum Sulphuricum</ProprietaryName>
<NonProprietaryName>Sodium Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180531</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>SODIUM SULFATE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71919-743-36</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (71919-743-36) > 300 TABLET in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>71919-0743-36</NDC11Code>
<ProductNDC>71919-743</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Natrum Muriaticum</ProprietaryName>
<NonProprietaryName>Sodium Chloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180531</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71919-744-36</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (71919-744-36) > 300 TABLET in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>71919-0744-36</NDC11Code>
<ProductNDC>71919-744</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Magnesia Phosphorica</ProprietaryName>
<NonProprietaryName>Magnesium Phosphate, Dibasic Trihydrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180531</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71919-745-36</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (71919-745-36) > 300 TABLET in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>71919-0745-36</NDC11Code>
<ProductNDC>71919-745</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kali Sulphuricum</ProprietaryName>
<NonProprietaryName>Potassium Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180531</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>POTASSIUM SULFATE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71919-746-36</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (71919-746-36) > 300 TABLET in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>71919-0746-36</NDC11Code>
<ProductNDC>71919-746</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kali Phosphoricum</ProprietaryName>
<NonProprietaryName>Dibasic Potassium Phosphate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180531</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>DIBASIC POTASSIUM PHOSPHATE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71919-747-36</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (71919-747-36) > 300 TABLET in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>71919-0747-36</NDC11Code>
<ProductNDC>71919-747</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kali Muriaticum</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180531</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71919-748-36</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (71919-748-36) > 300 TABLET in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>71919-0748-36</NDC11Code>
<ProductNDC>71919-748</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ferrum Phosphoricum</ProprietaryName>
<NonProprietaryName>Ferrosoferric Phosphate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180531</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>FERROSOFERRIC PHOSPHATE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
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<PackageDescription>1 BOTTLE, GLASS in 1 BOX (71919-749-36) > 300 TABLET in 1 BOTTLE, GLASS</PackageDescription>
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<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>CALCIUM FLUORIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
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<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDCCode>71919-751-36</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (71919-751-36) > 300 TABLET in 1 BOTTLE, GLASS</PackageDescription>
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<ProductNDC>71919-751</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Calcarea Sulphurica</ProprietaryName>
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<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180531</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>CALCIUM SULFATE ANHYDROUS</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>71919-752-36</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (71919-752-36) > 300 TABLET in 1 BOTTLE, GLASS</PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Silicea</ProprietaryName>
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<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>SILICON DIOXIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDCCode>71919-753-36</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (71919-753-36) > 300 TABLET in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>71919-0753-36</NDC11Code>
<ProductNDC>71919-753</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cell Salts Combination</ProprietaryName>
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<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180531</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>TRIBASIC CALCIUM PHOSPHATE; CALCIUM SULFATE ANHYDROUS; FERROSOFERRIC PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE; POTASSIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; CALCIUM FLUORIDE; SILICON DIOXIDE; POTASSIUM CHLORIDE</SubstanceName>
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<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>0135-0469-01</NDCCode>
<PackageDescription>36 TABLET, CHEWABLE in 1 BOTTLE (0135-0469-01)</PackageDescription>
<NDC11Code>00135-0469-01</NDC11Code>
<ProductNDC>0135-0469</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tums</ProprietaryName>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100407</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part331</ApplicationNumber>
<LabelerName>GlaxoSmithKline Consumer Healthcare Holdings (US) LLC</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0143-9161-10</NDCCode>
<PackageDescription>10 VIAL in 1 PACKAGE (0143-9161-10) / 513 mg in 1 VIAL (0143-9161-01) </PackageDescription>
<NDC11Code>00143-9161-10</NDC11Code>
<ProductNDC>0143-9161</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; ORAL</RouteName>
<StartMarketingDate>20230202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210274</ApplicationNumber>
<LabelerName>HIKMA PHARMACEUTICALS USA INC.</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>513</StrengthNumber>
<StrengthUnit>mg/mg</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Vancomycin Hydrochloride for Injection contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[l,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. Vancomycin Hydrochloride for Injection is a sterile, preservative-free, white, almost white to tan to brown, spray-dried powder, for preparing intravenous (IV) infusions, in single-dose vials each containing the equivalent of 500 mg, 750 mg, 1 g, 1.25 g or 1.5 g vancomycin base. Each 500 mg vial contains 500 mg vancomycin (equivalent to 513 mg vancomycin hydrochloride), 125 mg trehalose, 0.05 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 750 mg vial contains 750 mg vancomycin (equivalent to 769 mg vancomycin hydrochloride), 187.5 mg trehalose, 0.075 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1 g vial contains 1 g vancomycin (equivalent to 1.025 g vancomycin hydrochloride), 250 mg trehalose, 0.1 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.25 g vial contains 1.25 g vancomycin (equivalent to 1.28 g vancomycin hydrochloride), 312.5 mg trehalose, 0.125 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.5 g vial contains 1.5 g vancomycin (equivalent to 1.54 g vancomycin hydrochloride), 375 mg trehalose, 0.15 mg polysorbate 80, and hydrochloric acid used to adjust the pH. The spray-dried powder is reconstituted with Sterile Water for Injection which forms a clear solution and subsequently diluted prior to intravenous or oral administration [see Dosage and Administration (2.5, 2.8)]. Vancomycin Hydrochloride for Injection may also be diluted with a sweetening agent for oral administration [see Dosage and Administration (2.8)].</Description>
</NDC>
<NDC>
<NDCCode>0143-9161-25</NDCCode>
<PackageDescription>25 VIAL in 1 PACKAGE (0143-9161-25) / 513 mg in 1 VIAL (0143-9161-01) </PackageDescription>
<NDC11Code>00143-9161-25</NDC11Code>
<ProductNDC>0143-9161</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; ORAL</RouteName>
<StartMarketingDate>20230202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210274</ApplicationNumber>
<LabelerName>HIKMA PHARMACEUTICALS USA INC.</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>513</StrengthNumber>
<StrengthUnit>mg/mg</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Vancomycin Hydrochloride for Injection contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[l,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. Vancomycin Hydrochloride for Injection is a sterile, preservative-free, white, almost white to tan to brown, spray-dried powder, for preparing intravenous (IV) infusions, in single-dose vials each containing the equivalent of 500 mg, 750 mg, 1 g, 1.25 g or 1.5 g vancomycin base. Each 500 mg vial contains 500 mg vancomycin (equivalent to 513 mg vancomycin hydrochloride), 125 mg trehalose, 0.05 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 750 mg vial contains 750 mg vancomycin (equivalent to 769 mg vancomycin hydrochloride), 187.5 mg trehalose, 0.075 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1 g vial contains 1 g vancomycin (equivalent to 1.025 g vancomycin hydrochloride), 250 mg trehalose, 0.1 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.25 g vial contains 1.25 g vancomycin (equivalent to 1.28 g vancomycin hydrochloride), 312.5 mg trehalose, 0.125 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.5 g vial contains 1.5 g vancomycin (equivalent to 1.54 g vancomycin hydrochloride), 375 mg trehalose, 0.15 mg polysorbate 80, and hydrochloric acid used to adjust the pH. The spray-dried powder is reconstituted with Sterile Water for Injection which forms a clear solution and subsequently diluted prior to intravenous or oral administration [see Dosage and Administration (2.5, 2.8)]. Vancomycin Hydrochloride for Injection may also be diluted with a sweetening agent for oral administration [see Dosage and Administration (2.8)].</Description>
</NDC>
<NDC>
<NDCCode>0143-9162-10</NDCCode>
<PackageDescription>10 VIAL in 1 PACKAGE (0143-9162-10) / 1025 mg in 1 VIAL (0143-9162-01) </PackageDescription>
<NDC11Code>00143-9162-10</NDC11Code>
<ProductNDC>0143-9162</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; ORAL</RouteName>
<StartMarketingDate>20230202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210274</ApplicationNumber>
<LabelerName>HIKMA PHARMACEUTICALS USA INC.</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1025</StrengthNumber>
<StrengthUnit>mg/mg</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Vancomycin Hydrochloride for Injection contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[l,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. Vancomycin Hydrochloride for Injection is a sterile, preservative-free, white, almost white to tan to brown, spray-dried powder, for preparing intravenous (IV) infusions, in single-dose vials each containing the equivalent of 500 mg, 750 mg, 1 g, 1.25 g or 1.5 g vancomycin base. Each 500 mg vial contains 500 mg vancomycin (equivalent to 513 mg vancomycin hydrochloride), 125 mg trehalose, 0.05 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 750 mg vial contains 750 mg vancomycin (equivalent to 769 mg vancomycin hydrochloride), 187.5 mg trehalose, 0.075 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1 g vial contains 1 g vancomycin (equivalent to 1.025 g vancomycin hydrochloride), 250 mg trehalose, 0.1 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.25 g vial contains 1.25 g vancomycin (equivalent to 1.28 g vancomycin hydrochloride), 312.5 mg trehalose, 0.125 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.5 g vial contains 1.5 g vancomycin (equivalent to 1.54 g vancomycin hydrochloride), 375 mg trehalose, 0.15 mg polysorbate 80, and hydrochloric acid used to adjust the pH. The spray-dried powder is reconstituted with Sterile Water for Injection which forms a clear solution and subsequently diluted prior to intravenous or oral administration [see Dosage and Administration (2.5, 2.8)]. Vancomycin Hydrochloride for Injection may also be diluted with a sweetening agent for oral administration [see Dosage and Administration (2.8)].</Description>
</NDC>
<NDC>
<NDCCode>0143-9355-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (0143-9355-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0143-9355-01) </PackageDescription>
<NDC11Code>00143-9355-10</NDC11Code>
<ProductNDC>0143-9355</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20181003</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206616</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>VANCOMYCIN</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin Hydrochloride for Injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.</IndicationAndUsage>
<Description>Vancomycin Hydrochloride for Injection, USP is a lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 750 mg vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL, the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopasis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S-[3R*,6S*(S*),7S*,22S*,23R*,26R*,36S*,38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0143-9466-06</NDCCode>
<PackageDescription>6 BAG in 1 CARTON (0143-9466-06) / 250 mL in 1 BAG (0143-9466-01) </PackageDescription>
<NDC11Code>00143-9466-06</NDC11Code>
<ProductNDC>0143-9466</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tyzavan</ProprietaryName>
<NonProprietaryName>Vancomycin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251017</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211962</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>VANCOMYCIN</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>g/250mL</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TYZAVAN is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients (1 month and older) for whom appropriate dosing with this formulation can be achieved: : 1 Septicemia (1.1), 2 Infective Endocarditis (1.2), 3 Skin and Skin Structure Infections (1.3), 4 Bone Infections (1.4), 5 Lower Respiratory Tract Infections (1.5).</IndicationAndUsage>
<Description>TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags contain vancomycin as vancomycin hydrochloride. It is a tricyclic glycopeptide antibacterial drug derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-{[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]-oxy}-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino]valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36(iminometha-no)-13,16:31,35-dimetheno-1H,16H-[1,6,9]-oxadiazacyclohexadecino-[4,5-m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags are sterile, nonpyrogenic premixed 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL or 400 mL solution containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g vancomycin, respectively, as vancomycin hydrochloride. Each 100 mL of solution contains 1.36 g N-acetyl-D-alanine, 1.26 g L-lysine hydrochloride (monochloride) in water for injection. Hydrochloric acid and sodium hydroxide are used for pH adjustment. The pH is 4.5 to 5.5 and the osmolarity is 350 to 475 mOsmol/L.</Description>
</NDC>
<NDC>
<NDCCode>0143-9467-06</NDCCode>
<PackageDescription>6 BAG in 1 CARTON (0143-9467-06) / 350 mL in 1 BAG (0143-9467-01) </PackageDescription>
<NDC11Code>00143-9467-06</NDC11Code>
<ProductNDC>0143-9467</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tyzavan</ProprietaryName>
<NonProprietaryName>Vancomycin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251017</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211962</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>VANCOMYCIN</SubstanceName>
<StrengthNumber>1.75</StrengthNumber>
<StrengthUnit>g/350mL</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TYZAVAN is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients (1 month and older) for whom appropriate dosing with this formulation can be achieved: : 1 Septicemia (1.1), 2 Infective Endocarditis (1.2), 3 Skin and Skin Structure Infections (1.3), 4 Bone Infections (1.4), 5 Lower Respiratory Tract Infections (1.5).</IndicationAndUsage>
<Description>TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags contain vancomycin as vancomycin hydrochloride. It is a tricyclic glycopeptide antibacterial drug derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-{[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]-oxy}-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino]valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36(iminometha-no)-13,16:31,35-dimetheno-1H,16H-[1,6,9]-oxadiazacyclohexadecino-[4,5-m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags are sterile, nonpyrogenic premixed 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL or 400 mL solution containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g vancomycin, respectively, as vancomycin hydrochloride. Each 100 mL of solution contains 1.36 g N-acetyl-D-alanine, 1.26 g L-lysine hydrochloride (monochloride) in water for injection. Hydrochloric acid and sodium hydroxide are used for pH adjustment. The pH is 4.5 to 5.5 and the osmolarity is 350 to 475 mOsmol/L.</Description>
</NDC>
<NDC>
<NDCCode>0143-9468-06</NDCCode>
<PackageDescription>6 BAG in 1 CARTON (0143-9468-06) / 150 mL in 1 BAG (0143-9468-01) </PackageDescription>
<NDC11Code>00143-9468-06</NDC11Code>
<ProductNDC>0143-9468</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tyzavan</ProprietaryName>
<NonProprietaryName>Vancomycin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251017</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211962</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>VANCOMYCIN</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/150mL</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TYZAVAN is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients (1 month and older) for whom appropriate dosing with this formulation can be achieved: : 1 Septicemia (1.1), 2 Infective Endocarditis (1.2), 3 Skin and Skin Structure Infections (1.3), 4 Bone Infections (1.4), 5 Lower Respiratory Tract Infections (1.5).</IndicationAndUsage>
<Description>TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags contain vancomycin as vancomycin hydrochloride. It is a tricyclic glycopeptide antibacterial drug derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-{[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]-oxy}-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino]valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36(iminometha-no)-13,16:31,35-dimetheno-1H,16H-[1,6,9]-oxadiazacyclohexadecino-[4,5-m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags are sterile, nonpyrogenic premixed 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL or 400 mL solution containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g vancomycin, respectively, as vancomycin hydrochloride. Each 100 mL of solution contains 1.36 g N-acetyl-D-alanine, 1.26 g L-lysine hydrochloride (monochloride) in water for injection. Hydrochloric acid and sodium hydroxide are used for pH adjustment. The pH is 4.5 to 5.5 and the osmolarity is 350 to 475 mOsmol/L.</Description>
</NDC>
</NDCList>