FDA.reportPublic FDA data

Steritalc

Product NDC
62327-444
11-digit product format
623270444
Labeler code
62327
Product ID
62327-444_386130d4-1b0d-5e87-e063-6394a90aefa7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Talc
Dosage form
POWDER
Route
INTRAPLEURAL
Labeler
Novatech SA
Application
NDA205555
Marketing category
NDA
Marketing start
2017-08-01
Substance
TALC
Active strength
4 g/50mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Steritalc
Brand name suffix
4g
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TALC4 g/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7SEV7J4R1U
Rxcui2003393, 2003398, 2003400, 2003402, 2003403, 2003405

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62327-444-04Steritalc4g50 mL in 1 VIAL, GLASSPOWDER507
62327-444-44Steritalc4g4 in 1 BOXPOWDER47

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62327-444-04EA - Each62327-444ce2a2ed8-232c-4665-8957-2b6c6930ce5012021-09-07
62327-444-44EA - Each62327-444cdb239c8-da8e-4b5d-8590-6b97032854e112021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62327-444STERITALC 4G (TALC) POWDER STERITALC 2G (TALC) POWDER STERITALC 3G (TALC) POWDER [NOVATECH SA]5Current NDC, Legacy NDC, 2 package rows20250508_c94e51d9-beef-4b06-e053-2a95a90a754a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2003398Steritalc 2 GM Powder for Intrapleural SuspensionPSNc94e51d9-beef-4b06-e053-2a95a90a754a7
2003402Steritalc 3 GM Powder for Intrapleural SuspensionPSNc94e51d9-beef-4b06-e053-2a95a90a754a7
2003405Steritalc 4 GM Powder for Intrapleural SuspensionPSNc94e51d9-beef-4b06-e053-2a95a90a754a7
2003393talc 2 GM Powder for Intrapleural SuspensionPSNc94e51d9-beef-4b06-e053-2a95a90a754a7
2003400talc 3 GM Powder for Intrapleural SuspensionPSNc94e51d9-beef-4b06-e053-2a95a90a754a7
2003403talc 4 GM Powder for Intrapleural SuspensionPSNc94e51d9-beef-4b06-e053-2a95a90a754a7
2003398talc 2000 MG Topical Powder [Steritalc]SBDc94e51d9-beef-4b06-e053-2a95a90a754a7
2003402talc 3000 MG Topical Powder [Steritalc]SBDc94e51d9-beef-4b06-e053-2a95a90a754a7
2003405talc 4000 MG Topical Powder [Steritalc]SBDc94e51d9-beef-4b06-e053-2a95a90a754a7
2003393talc 2000 MG Topical PowderSCDc94e51d9-beef-4b06-e053-2a95a90a754a7
2003400talc 3000 MG Topical PowderSCDc94e51d9-beef-4b06-e053-2a95a90a754a7
2003403talc 4000 MG Topical PowderSCDc94e51d9-beef-4b06-e053-2a95a90a754a7
2003398Steritalc 2 GM Powder for Intrapleural SuspensionSYc94e51d9-beef-4b06-e053-2a95a90a754a7
2003398Steritalc 2000 MG Topical PowderSYc94e51d9-beef-4b06-e053-2a95a90a754a7
2003402Steritalc 3 GM Powder for Intrapleural SuspensionSYc94e51d9-beef-4b06-e053-2a95a90a754a7
2003402Steritalc 3000 MG Topical PowderSYc94e51d9-beef-4b06-e053-2a95a90a754a7
2003405Steritalc 4 GM Powder for Intrapleural SuspensionSYc94e51d9-beef-4b06-e053-2a95a90a754a7
2003405Steritalc 4000 MG Topical PowderSYc94e51d9-beef-4b06-e053-2a95a90a754a7
2003393talc 2 GM Powder for Intrapleural SuspensionSYc94e51d9-beef-4b06-e053-2a95a90a754a7
2003400talc 3 GM Powder for Intrapleural SuspensionSYc94e51d9-beef-4b06-e053-2a95a90a754a7
2003403talc 4 GM Powder for Intrapleural SuspensionSYc94e51d9-beef-4b06-e053-2a95a90a754a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62327-444-046232704440450 mL in 1 VIAL, GLASS50 mlHistorical
62327-444-44623270444444 VIAL, GLASS in 1 BOX (62327-444-44) / 50 mL in 1 VIAL, GLASS (62327-444-04) 2017-08-010000-00-00NoNoCurrent