FDA.reportPublic FDA data

Sterile Talc

Product NDC
63256-200
11-digit product format
632560200
Labeler code
63256
Product ID
63256-200_ffa7f6f2-0d63-42b4-bb48-34217d871a91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Talc
Dosage form
POWDER
Route
INTRAPLEURAL
Labeler
Bryan Corporation
Application
NDA021388
Marketing category
NDA
Marketing start
2003-12-15
Marketing end
0000-00-00
Substance
TALC
Active strength
5 g/100mL
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63256-200-052020-01-31C16284748780-19d75b9d1-1647-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use STERILE TALC POWDER safely and effectively. See full prescribing information for STERILE TALC POWDER. STERILE TALC POWDER (talc), for intrapleural use Initial U.S. Approval: 2003
63256-200-102020-01-31C16284748780-19d75b9d1-1647-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use STERILE TALC POWDER safely and effectively. See full prescribing information for STERILE TALC POWDER. STERILE TALC POWDER (talc), for intrapleural use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63256-200-05Sterile Talc100 mL in 1 BOTTLEPOWDER1002
63256-200-05Sterile Talc1 in 1 POUCHPOWDER12
63256-200-10Sterile Talc100 mL in 1 BOTTLEPOWDER1002
63256-200-10Sterile Talc10 in 1 BOXPOWDER102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63256-200-05EA - Each63256-200bbde1785-4915-40e3-ab37-af52c6be7c1312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TalcACTIVE INGREDIENT7SEV7J4R1USTERILE TALC (TALC) POWDER [BRYAN CORPORATION]2
TalcACTIVE MOIETY7SEV7J4R1USTERILE TALC (TALC) POWDER [BRYAN CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63256-200STERILE TALC (TALC) POWDER [BRYAN CORPORATION]2Legacy NDC, 4 package rows20141125_72b10d15-8337-49ab-ad8d-0e990192598e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876229talc 5 GM Intrapleural PowderPSN72b10d15-8337-49ab-ad8d-0e990192598e2
876229talc 5000 MG Topical PowderSCD72b10d15-8337-49ab-ad8d-0e990192598e2
876229sterile talc 5 GM Intrapleural PowderSY72b10d15-8337-49ab-ad8d-0e990192598e2
876229talc 5 GM Intrapleural PowderSY72b10d15-8337-49ab-ad8d-0e990192598e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
63256-200-0563256020005100 mL in 1 BOTTLE100 mlHistorical
63256-200-1063256020010100 mL in 1 BOTTLE100 mlHistorical