Monsels Solution

Product NDC
48992-001
11-digit product format
489920001
Labeler code
48992
Product ID
48992-001_cf32cbad-332c-2546-e053-2a95a90a5b30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ferric Subsulfate
Dosage form
PASTE
Route
TOPICAL
Labeler
Gynex Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-03-13
Marketing end
0000-00-00
Substance
FERRIC SUBSULFATE
Active strength
210 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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
04cdd491-d111-4bc2-9549-75c575e1bd4bProduct name120200714
8390fb8b-6c75-416c-a9a1-70e8ed493b73Product name120200611
96a528e9-23e2-495f-81b9-ae87df2f7552Product name120191120
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
48992-001-012023-01-30C16284748780-1f386c649-e1f4-0266-e053-dadaa90a7c1a170ce265-2951-47a6-8f56-a27cc39cbdf8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48992-001-01Monsels Solution14 g in 1 VIAL, SINGLE-DOSEPASTE142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48992-001MONSELS SOLUTION (FERRIC SUBSULFATE) PASTE [GYNEX CORPORATION]2Legacy NDC, 1 package rows20211027_170ce265-2951-47a6-8f56-a27cc39cbdf8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831162Monsel's ferric subsulfate 20 % - 22 % Topical SolutionPSN170ce265-2951-47a6-8f56-a27cc39cbdf82
831162ferric subsulfate solution 220 MG/ML Topical SolutionSCD170ce265-2951-47a6-8f56-a27cc39cbdf82
831162Monsel's 20 % - 22 % Topical SolutionSY170ce265-2951-47a6-8f56-a27cc39cbdf82
831162Monsel's 20 % Topical SolutionSY170ce265-2951-47a6-8f56-a27cc39cbdf82
831162Monsel's 22 % Topical SolutionSY170ce265-2951-47a6-8f56-a27cc39cbdf82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48992-001-014899200010114 g in 1 VIAL, SINGLE-DOSE (48992-001-01) 14 g2020-03-130000-00-00NoNoCurrent