FDA.reportPublic FDA data

FERROUS SULFATE

Product NDC
54738-963
Requested package NDC
54738-963-13
11-digit product format
547380963
Labeler code
54738
Product ID
54738-963_2a327c66-d561-6a9b-e063-6294a90a5d0a
Type
HUMAN OTC DRUG
Nonproprietary name
FERROUS SULFATE
Dosage form
TABLET
Route
ORAL
Labeler
Richmond Pharmaceuticals, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2015-06-01
Substance
FERROUS SULFATE
Active strength
325 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FERROUS SULFATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FERROUS SULFATE325 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
39R4TAN1VTInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310325Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
58dd4f30-980b-44bc-9f8e-8d4626854b91Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54738-963-01FERROUS SULFATE100 in 1 BOTTLETABLET1004
54738-963-03FERROUS SULFATE1000 in 1 BOTTLETABLET10004
54738-963-13Ferrous Sulfate100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54738-963-01EA - Each54738-9632f1716c6-9306-44c0-a614-de0e8a5c702212018-11-06
54738-963-03EA - Each54738-963203a1097-af9d-464d-85dc-a5055cd0fac212018-11-06
54738-963-13EA - Each54738-96327bb23cb-635d-4008-8642-e27e7f04a27312013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FERROUS SULFATEACTIVE INGREDIENT39R4TAN1VTFERROUS SULFATE TABLET [RICHMOND PHARMACEUTICALS INC.]1
FERROUS CATIONACTIVE MOIETYGW89581OWRFERROUS SULFATE TABLET [RICHMOND PHARMACEUTICALS INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFERROUS SULFATE TABLET [RICHMOND PHARMACEUTICALS INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FERROUS SULFATE TABLET [RICHMOND PHARMACEUTICALS INC.]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPFERROUS SULFATE TABLET [RICHMOND PHARMACEUTICALS INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFERROUS SULFATE TABLET [RICHMOND PHARMACEUTICALS INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8FERROUS SULFATE TABLET [RICHMOND PHARMACEUTICALS INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFERROUS SULFATE TABLET [RICHMOND PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FERROUS SULFATE TABLET [RICHMOND PHARMACEUTICALS INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQFERROUS SULFATE TABLET [RICHMOND PHARMACEUTICALS INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFERROUS SULFATE TABLET [RICHMOND PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54738-963FERROUS SULFATE TABLET [RICHMOND PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 2 package rows20241228_58dd4f30-980b-44bc-9f8e-8d4626854b91.zip
54738-963FERROUS SULFATE TABLET [RICHMOND PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 1 package rows20241228_5514d582-19b5-4f1e-b794-f790afb8211c.zip

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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FERROUS SULFATEFERROUS SULFATERichmond Pharmaceuticals, Inc.58dd4f30-980b-44bc-9f8e-8d4626854b912024-12-26WarningsExact identifier
ndc (product): 54738-963
Ferrous SulfateFERROUS SULFATERichmond Pharmaceuticals Inc.5514d582-19b5-4f1e-b794-f790afb8211c2024-12-26Boxed warning, WarningsExact identifier
ndc (package): 54738-963-13
ndc (product): 54738-963
ndc11 (package): 54738096313

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310325ferrous sulfate 325 MG (iron 65 MG) Oral TabletPSN58dd4f30-980b-44bc-9f8e-8d4626854b914
310325ferrous sulfate 325 MG Oral TabletSCD58dd4f30-980b-44bc-9f8e-8d4626854b914
310325ferrous sulfate 324 MG (iron 65 MG) Oral TabletSY58dd4f30-980b-44bc-9f8e-8d4626854b914
310325ferrous sulfate 325 MG (iron 65 MG) Oral TabletSY58dd4f30-980b-44bc-9f8e-8d4626854b914
310325FESO4 325 MG Oral TabletSY58dd4f30-980b-44bc-9f8e-8d4626854b914
310325ferrous sulfate 325 MG (iron 65 MG) Oral TabletPSN5514d582-19b5-4f1e-b794-f790afb8211c3
310325ferrous sulfate 325 MG Oral TabletSCD5514d582-19b5-4f1e-b794-f790afb8211c3
310325ferrous sulfate 324 MG (iron 65 MG) Oral TabletSY5514d582-19b5-4f1e-b794-f790afb8211c3
310325ferrous sulfate 325 MG (iron 65 MG) Oral TabletSY5514d582-19b5-4f1e-b794-f790afb8211c3
310325FESO4 325 MG Oral TabletSY5514d582-19b5-4f1e-b794-f790afb8211c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54738-963-1354738096313100 TABLET in 1 BOTTLE (54738-963-13) 100 tablet2008-11-050000-00-00NoNoCurrent