Steritalc

Product NDC
62327-222
11-digit product format
623270222
Labeler code
62327
Product ID
62327-222_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
2017-11-01
Substance
TALC
Active strength
2 g/50mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct62327-222UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62327-22262327-222-42UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N205555-001STERITALCTALC2GM/VIALPOWDER / INTRAPLEURALRLD2017-05-01
N205555-002STERITALCTALC3GM/VIALPOWDER / INTRAPLEURALRLD2017-05-01
N205555-003STERITALCTALC4GM/VIALPOWDER / INTRAPLEURALRLD, RS2017-05-01

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N205555-001STERITALC2GM/VIALPOWDER / INTRAPLEURALRLD2017-05-01caaa826d4ba7…
2026-08-18 06:07:402026-07N205555-002STERITALC3GM/VIALPOWDER / INTRAPLEURALRLD2017-05-01caaa826d4ba7…
2026-08-18 06:07:402026-07N205555-003STERITALC4GM/VIALPOWDER / INTRAPLEURALRLD, RS2017-05-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N205555-001STERITALC2GM/VIALPOWDER / INTRAPLEURALRLD2017-05-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205555-002STERITALC3GM/VIALPOWDER / INTRAPLEURALRLD2017-05-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205555-003STERITALC4GM/VIALPOWDER / INTRAPLEURALRLD, RS2017-05-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205555-001STERITALC2GM/VIALPOWDER / INTRAPLEURALRLD2017-05-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205555-002STERITALC3GM/VIALPOWDER / INTRAPLEURALRLD2017-05-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205555-003STERITALC4GM/VIALPOWDER / INTRAPLEURALRLD, RS2017-05-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N205555-001STERITALC2GM/VIALPOWDER / INTRAPLEURALRLD2017-05-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205555-002STERITALC3GM/VIALPOWDER / INTRAPLEURALRLD2017-05-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205555-003STERITALC4GM/VIALPOWDER / INTRAPLEURALRLD, RS2017-05-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205555-001STERITALC2GM/VIALPOWDER / INTRAPLEURALRLD2017-05-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205555-002STERITALC3GM/VIALPOWDER / INTRAPLEURALRLD2017-05-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205555-003STERITALC4GM/VIALPOWDER / INTRAPLEURALRLD, RS2017-05-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205555-001STERITALC2GM/VIALPOWDER / INTRAPLEURALRLD2017-05-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205555-002STERITALC3GM/VIALPOWDER / INTRAPLEURALRLD2017-05-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205555-003STERITALC4GM/VIALPOWDER / INTRAPLEURALRLD, RS2017-05-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205555-001STERITALC2GM/VIALPOWDER / INTRAPLEURALRLD2017-05-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205555-002STERITALC3GM/VIALPOWDER / INTRAPLEURALRLD2017-05-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205555-003STERITALC4GM/VIALPOWDER / INTRAPLEURALRLD, RS2017-05-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205555-001STERITALC2GM/VIALPOWDER / INTRAPLEURALRLD2017-05-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205555-002STERITALC3GM/VIALPOWDER / INTRAPLEURALRLD2017-05-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205555-003STERITALC4GM/VIALPOWDER / INTRAPLEURALRLD, RS2017-05-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205555-001STERITALC2GM/VIALPOWDER / INTRAPLEURALRLD2017-05-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205555-002STERITALC3GM/VIALPOWDER / INTRAPLEURALRLD2017-05-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205555-003STERITALC4GM/VIALPOWDER / INTRAPLEURALRLD, RS2017-05-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205555-001STERITALC2GM/VIALPOWDER / INTRAPLEURALRLD2017-05-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205555-002STERITALC3GM/VIALPOWDER / INTRAPLEURALRLD2017-05-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205555-003STERITALC4GM/VIALPOWDER / INTRAPLEURALRLD, RS2017-05-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205555-001STERITALC2GM/VIALPOWDER / INTRAPLEURALRLD2017-05-01d06236e962d9…
2024-10-29 15:01 UTC2024-10N205555-002STERITALC3GM/VIALPOWDER / INTRAPLEURALRLD2017-05-01d06236e962d9…
2024-10-29 15:01 UTC2024-10N205555-003STERITALC4GM/VIALPOWDER / INTRAPLEURALRLD, RS2017-05-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205555-001STERITALC2GM/VIALPOWDER / INTRAPLEURALRLD2017-05-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205555-002STERITALC3GM/VIALPOWDER / INTRAPLEURALRLD2017-05-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205555-003STERITALC4GM/VIALPOWDER / INTRAPLEURALRLD, RS2017-05-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205555-001STERITALC2GM/VIALPOWDER / INTRAPLEURALRLD2017-05-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205555-002STERITALC3GM/VIALPOWDER / INTRAPLEURALRLD2017-05-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205555-003STERITALC4GM/VIALPOWDER / INTRAPLEURALRLD, RS2017-05-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205555-001STERITALC2GM/VIALPOWDER / INTRAPLEURALRLD2017-05-011e350fbaab3a…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205555-001ODE-1432024-05-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205555-001ODE-1912024-05-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205555-002ODE-1432024-05-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205555-002ODE-1912024-05-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205555-003ODE-1432024-05-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205555-003ODE-1912024-05-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205555-001ODE-1432024-05-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205555-001ODE-1912024-05-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205555-002ODE-1432024-05-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205555-002ODE-1912024-05-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205555-003ODE-1432024-05-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205555-003ODE-1912024-05-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205555-001ODE-1432024-05-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205555-001ODE-1912024-05-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205555-002ODE-1432024-05-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205555-002ODE-1912024-05-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205555-003ODE-1432024-05-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205555-003ODE-1912024-05-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205555-001ODE-1432024-05-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205555-001ODE-1912024-05-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205555-002ODE-1432024-05-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205555-002ODE-1912024-05-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205555-003ODE-1432024-05-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205555-003ODE-1912024-05-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205555-001ODE-1432024-05-01d06236e962d9…
2024-10-29 15:01 UTC2024-10N205555-001ODE-1912024-05-01d06236e962d9…
2024-10-29 15:01 UTC2024-10N205555-002ODE-1432024-05-01d06236e962d9…
2024-10-29 15:01 UTC2024-10N205555-002ODE-1912024-05-01d06236e962d9…
2024-10-29 15:01 UTC2024-10N205555-003ODE-1432024-05-01d06236e962d9…
2024-10-29 15:01 UTC2024-10N205555-003ODE-1912024-05-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205555-001ODE-1432024-05-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205555-001ODE-1912024-05-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205555-002ODE-1432024-05-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205555-002ODE-1912024-05-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205555-003ODE-1432024-05-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205555-003ODE-1912024-05-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205555-001ODE-1432024-05-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205555-001ODE-1912024-05-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205555-002ODE-1432024-05-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205555-002ODE-1912024-05-01301d65b070ca…

Additional Listing Data#

Finished product
Yes
Brand name base
Steritalc
Brand name suffix
2g
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TALC2 g/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7SEV7J4R1UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2003393Internal RxNorm lookup
2003398Internal RxNorm lookup
2003400Internal RxNorm lookup
2003402Internal RxNorm lookup
2003403Internal RxNorm lookup
2003405Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c94e51d9-beef-4b06-e053-2a95a90a754aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62327-222-02Steritalc2g50 mL in 1 VIAL, GLASSPOWDER507
62327-222-42Steritalc2g4 in 1 BOXPOWDER47

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62327-222-02EA - Each62327-2222235eaac-5050-4a28-bfbe-ce0cbb65501312021-09-07
62327-222-42EA - Each62327-222e5e0d915-5957-40f4-8113-c7723e245e6812021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62327-222STERITALC 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Steritalc 2gTALCNovatech SAc94e51d9-beef-4b06-e053-2a95a90a754a2025-06-25Warnings, Adverse reactionsExact identifier
application applno (NDA): 205555
application number: NDA205555
ndc (product): 62327-222

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
62327-222-026232702220250 mL in 1 VIAL, GLASS50 mlHistorical
62327-222-42623270222424 VIAL, GLASS in 1 BOX (62327-222-42) / 50 mL in 1 VIAL, GLASS (62327-222-02) 2017-11-010000-00-00NoNoCurrent