NDC 50604-7215-2 - ZACTRAN

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
50604-7215
Requested NDC
50604-7215-2
Package NDCs from labels
50604-7215-1, 50604-7215-2, 50604-7215-3
Manufacturer
Merial, Inc.
Effective date
2016-08-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ZACTRAN ® (gamithromycin)Merial, Inc.2016-08-30PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
gamithromycinACTIVE INGREDIENTZE856183S0ZACTRAN (GAMITHROMYCIN) INJECTION, SOLUTION [MERIAL LIMITED]2
gamithromycinACTIVE MOIETYZE856183S0ZACTRAN (GAMITHROMYCIN) INJECTION, SOLUTION [MERIAL LIMITED]2
glycerol formalINACTIVE INGREDIENT3L7GR2604EZACTRAN (GAMITHROMYCIN) INJECTION, SOLUTION [MERIAL LIMITED]2
monothioglycerolINACTIVE INGREDIENTAAO1P0WSXJZACTRAN (GAMITHROMYCIN) INJECTION, SOLUTION [MERIAL LIMITED]2
succinic acidINACTIVE INGREDIENTAB6MNQ6J6LZACTRAN (GAMITHROMYCIN) INJECTION, SOLUTION [MERIAL LIMITED]2

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 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OMEOSPORT.ALPHA.-KETOGLUTARIC ACID - ACONITIC ACID, CIS - ADENOSINE TRIPHOSPHATE - ALPHA LIPOIC ACID - ASCORBIC ACID - ASIAN GINSENG - BARIUM CATION - BEET - CEROUS OXALATE NONAHYDRATE - COENZYME A - CYSTEINE - FUMARIC ACID - LACTIC ACID, DL - MAGNESIUM CARBONATE - MALIC ACID - MANGANESE PHOSPHATE, DIBASIC - PORK - PYRIDOXINE HYDROCHLORIDE - RIBOFLAVIN - SODIUM DIETHYL OXALACETATE - SODIUM PYRUVATE - SUCCINIC ACID - SUS SCROFA ADRENAL GLAND - THIAMINE HYDROCHLORIDE - SUS SCROFA EMBRYO -Guna spa119a205d-0074-48ff-ac78-e2300db452272018-12-21WarningsExact identifier
unii: AB6MNQ6J6L

Reported adverse events (FAERS/openFDA)#

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