FDA.reportPublic FDA data

FERROUS SULFATE

Product NDC
53807-177
11-digit product format
538070177
Labeler code
53807
Product ID
53807-177_2145d850-8607-4fb6-9ffb-a22e0adb7411
Type
HUMAN OTC DRUG
Nonproprietary name
FERROUS SULFATE
Dosage form
ELIXIR
Route
ORAL
Labeler
Rij Pharmaceutical Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1999-03-16
Marketing end
0000-00-00
Substance
FERROUS SULFATE
Active strength
220 mg/5mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53807-177-082020-01-31C16284748780-19d75b9d0-2452-f424-e053-dadaa90a57ceDrug Facts
53807-177-162020-01-31C16284748780-19d75b9d0-2452-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53807-177-08FERROUS SULFATE236 mL in 1 BOTTLEELIXIR2362
53807-177-16FERROUS SULFATE473 mL in 1 BOTTLEELIXIR4732

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FERROUS SULFATEACTIVE INGREDIENT39R4TAN1VTFERROUS SULFATE ELIXIR [RIJ PHARMACEUTICAL CORPORATION]1
FERROUS CATIONACTIVE MOIETYGW89581OWRFERROUS SULFATE ELIXIR [RIJ PHARMACEUTICAL CORPORATION]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPFERROUS SULFATE ELIXIR [RIJ PHARMACEUTICAL CORPORATION]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8FERROUS SULFATE ELIXIR [RIJ PHARMACEUTICAL CORPORATION]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUFERROUS SULFATE ELIXIR [RIJ PHARMACEUTICAL CORPORATION]1
SUCROSEINACTIVE INGREDIENTC151H8M554FERROUS SULFATE ELIXIR [RIJ PHARMACEUTICAL CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RFERROUS SULFATE ELIXIR [RIJ PHARMACEUTICAL CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53807-177FERROUS SULFATE ELIXIR [RIJ PHARMACEUTICAL CORPORATION]2Legacy NDC, 2 package rows20180502_a017eb78-8c70-4b59-b7c0-22ec6945c1a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702249ferrous sulfate 220 MG (iron 44 MG) in 5 mL Oral SolutionPSNa017eb78-8c70-4b59-b7c0-22ec6945c1a12
702249ferrous sulfate 44 MG/ML Oral SolutionSCDa017eb78-8c70-4b59-b7c0-22ec6945c1a12
702249ferrous sulfate 220 MG (iron 44 MG) per 5 ML Oral SolutionSYa017eb78-8c70-4b59-b7c0-22ec6945c1a12
702249ferrous sulfate 300 MG per 6.8 ML Oral SolutionSYa017eb78-8c70-4b59-b7c0-22ec6945c1a12
702249FESO4 44 MG/ML Oral SolutionSYa017eb78-8c70-4b59-b7c0-22ec6945c1a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53807-177-0853807017708236 mL in 1 BOTTLE236 mlHistorical
53807-177-1653807017716473 mL in 1 BOTTLE473 mlHistorical