FDA.reportPublic FDA data

Ferric Subsulfate

Product NDC
59365-6065
11-digit product format
593656065
Labeler code
59365
Product ID
59365-6065_d8d4fa24-4aef-4d37-9434-5901f439369e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ferric Subsulfate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
CooperSurgical, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1992-10-01
Marketing end
0000-00-00
Substance
FERRIC SUBSULFATE
Active strength
259 mg/g
Pharmacologic classes
Iron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59365-6065-12021-01-29C16284748780-1ba0f9c33-5ea4-a910-e053-dadaa90a0b85AstrinGyn

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59365-6065-0Ferric Subsulfate8 g in 1 VIAL, SINGLE-USESOLUTION811
59365-6065-1Ferric Subsulfate12 in 1 CARTONSOLUTION1211

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59365-6065-0GM - Gram59365-60654f54df4e-c757-4096-ae85-3e500090433812013-11-04
59365-6065-1GM - Gram59365-6065501e7678-564d-4720-93d8-c8db9232bd4d12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FERRIC SUBSULFATEACTIVE INGREDIENT3QJ8WS6V8HFERRIC SUBSULFATE SOLUTION [COOPERSURGICAL, INC.]9
FERRIC CATIONACTIVE MOIETY91O4LML611FERRIC SUBSULFATE SOLUTION [COOPERSURGICAL, INC.]9
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7FERRIC SUBSULFATE SOLUTION [COOPERSURGICAL, INC.]9
GLYCERININACTIVE INGREDIENTPDC6A3C0OXFERRIC SUBSULFATE SOLUTION [COOPERSURGICAL, INC.]9
POVIDONESINACTIVE INGREDIENTFZ989GH94EFERRIC SUBSULFATE SOLUTION [COOPERSURGICAL, INC.]9
WATERINACTIVE INGREDIENT059QF0KO0RFERRIC SUBSULFATE SOLUTION [COOPERSURGICAL, INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59365-6065FERRIC SUBSULFATE SOLUTION [COOPERSURGICAL, INC.]11Legacy NDC, 2 package rows20210318_e93bce8b-de3b-4477-be41-d361e68849c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
544860ferric subsulfate 259 MG/GM Topical SolutionPSNe93bce8b-de3b-4477-be41-d361e68849c611
544860ferric subsulfate solution 259 MG/ML Topical SolutionSCDe93bce8b-de3b-4477-be41-d361e68849c611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59365-6065-0593656065008 g in 1 VIAL, SINGLE-USE8 gHistorical
59365-6065-15936560650112 VIAL, SINGLE-USE in 1 CARTON (59365-6065-1) > 8 g in 1 VIAL, SINGLE-USE (59365-6065-0) 1992-10-010000-00-00NoNoCurrent