FDA.reportPublic FDA data

ACCRUFER

Product NDC
73059-001
11-digit product format
730590001
Labeler code
73059
Product ID
73059-001_4692a8dd-4627-f0eb-e063-6294a90aed63
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ferric Maltol
Dosage form
CAPSULE
Route
ORAL
Labeler
Shield TX (UK) Ltd
Application
NDA212320
Marketing category
NDA
Marketing start
2021-07-01
Substance
FERRIC MALTOL
Active strength
30 mg/1
Pharmacologic classes
Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ACCRUFER
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FERRIC MALTOL30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMA10QYF1Z0
Rxcui2539943, 2539949

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04cdd491-d111-4bc2-9549-75c575e1bd4bProduct name120200714
8390fb8b-6c75-416c-a9a1-70e8ed493b73Product name120200611
96a528e9-23e2-495f-81b9-ae87df2f7552Product name120191120
3df56c93-5837-4523-aac2-4b1ec48b9676Product name220160719
a883b7cc-d320-41d7-92ae-c873457ae641Product name120151116
bb23e78e-9e64-4037-a1c1-0e1d8762700eProduct name120150325
ef06c001-572c-d95e-42f6-ee83da75673aProduct name120140508
fd21f957-6863-d07b-5a35-250186878716Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73059-001-06ACCRUFER1 in 1 CARTONCAPSULE124
73059-001-06ACCRUFER6 in 1 BOTTLE, PLASTICCAPSULE624
73059-001-10ACCRUFER1 in 1 CARTONCAPSULE124
73059-001-10ACCRUFER10 in 1 BOTTLE, PLASTICCAPSULE1024
73059-001-60ACCRUFER60 in 1 BOTTLE, PLASTICCAPSULE6024
73059-001-60ACCRUFER1 in 1 CARTONCAPSULE124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73059-001-60EA - Each73059-00133fce7d5-7f78-441a-9e42-3437ac3878cb12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73059-001ACCRUFER (FERRIC MALTOL) CAPSULE [SHIELD TX (UK) LTD]22Current NDC, Legacy NDC, 6 package rows20231207_367ac157-2d25-4f34-99ce-b126e0f03851.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2539949ACCRUFER 30 MG Oral CapsulePSN367ac157-2d25-4f34-99ce-b126e0f0385124
2539943ferric maltol (iron 30 MG) 30 MG Oral CapsulePSN367ac157-2d25-4f34-99ce-b126e0f0385124
2539949ferric maltol 30 MG Oral Capsule [Accrufer]SBD367ac157-2d25-4f34-99ce-b126e0f0385124
2539943ferric maltol 30 MG Oral CapsuleSCD367ac157-2d25-4f34-99ce-b126e0f0385124
2539949Accrufer 30 MG Oral CapsuleSY367ac157-2d25-4f34-99ce-b126e0f0385124
2539943ferric maltol (iron 30 MG) 30 MG Oral CapsuleSY367ac157-2d25-4f34-99ce-b126e0f0385124

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
73059-001-06730590001061 BOTTLE, PLASTIC in 1 CARTON (73059-001-06) > 6 CAPSULE in 1 BOTTLE, PLASTIC2021-11-010000-00-00YesNoCurrent
73059-001-10730590001101 BOTTLE, PLASTIC in 1 CARTON (73059-001-10) / 10 CAPSULE in 1 BOTTLE, PLASTIC2022-04-010000-00-00YesNoCurrent
73059-001-60730590001601 BOTTLE, PLASTIC in 1 CARTON (73059-001-60) / 60 CAPSULE in 1 BOTTLE, PLASTIC2021-07-010000-00-00NoNoCurrent