FDA.reportPublic FDA data

NDC 52959-378 - Trazamine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
52959-378
Package NDCs from labels
52959-378-30
Manufacturer
Physician Therapeutics LLC | Targeted Medical Pharma, Inc. | Pliva Hrvatska d.o.o. | H.J. Harkins Company, Inc.
Effective date
2011-08-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TrazaminePhysician Therapeutics LLC | Targeted Medical Pharma, Inc. | Pliva Hrvatska d.o.o. | H.J. Harkins Company, Inc.2011-08-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-378-30Trazamine30 in 1 BOTTLETABLET3050 mg11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-378TRAZAMINE (TRAZODONE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]11Unmatched20110812_d5f0457f-b722-48b7-8901-61da7fbb4090.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHOLINEACTIVE INGREDIENTN91BDP6H0XTRAZAMINE (TRAZODONE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]11
TRAZODONE HYDROCHLORIDEACTIVE INGREDIENT6E8ZO8LRNMTRAZAMINE (TRAZODONE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]11
CHOLINEACTIVE MOIETYN91BDP6H0XTRAZAMINE (TRAZODONE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]11
TRAZODONEACTIVE MOIETYYBK48BXK30TRAZAMINE (TRAZODONE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]11
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRAZAMINE (TRAZODONE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAZAMINE (TRAZODONE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]11
GELATININACTIVE INGREDIENT2G86QN327LTRAZAMINE (TRAZODONE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAZAMINE (TRAZODONE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]11
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DTRAZAMINE (TRAZODONE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRAZAMINE (TRAZODONE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAZAMINE (TRAZODONE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]11

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 35 of 35 · 683 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ThyrotoxCHONDRUS CRISPUS, FUCUS VESICULOSUS, THYROIDINUM, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, IODIUM, KALI CARBONICUM, PHOSPHORUS, PULSATILLA (VULGARIS), SILICEABioActive Nutritional, Inc.e229a260-13f3-4136-b325-9a8954f8a3272016-08-10WarningsExact identifier
unii: ETJ7Z6XBU4
TeethingARNICA MONTANA, TRIFOLIUM PRATENSE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CHAMOMILLA, KREOSOTUM, SILICEABioActive Nutritional, Inc.f39c9feb-f567-43a2-a026-2a581aeeed9d2016-07-27WarningsExact identifier
unii: ETJ7Z6XBU4
f6b33067-062a-4da6-b5cc-a0ad73a348f2d5f0457f-b722-48b7-8901-61da7fbb40902011-08-01Warnings, Adverse reactionsExact identifier
spl id: f6b33067-062a-4da6-b5cc-a0ad73a348f2
spl set id: d5f0457f-b722-48b7-8901-61da7fbb4090

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.