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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63256-200		I	Inactivated by FDA	2026-08-17
excluded package	package	63256-200	63256-200-05	I	Inactivated by FDA	2026-08-17
excluded package	package	63256-200	63256-200-10	I	Inactivated by FDA	2026-08-17

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 2 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63256-200-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63256-200-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63256-200-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63256-200-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63256-200-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63256-200-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63256-200-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63256-200-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63256-200-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63256-200-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63256-200-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63256-200-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63256-200-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63256-200-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63256-200-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63256-200-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63256-200-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63256-200-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63256-200-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63256-200-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63256-200-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63256-200-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63256-200-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63256-200-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63256-200-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63256-200-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63256-200-05	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63256-200-10	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63256-200-05	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63256-200-10	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	63256-200-05	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	63256-200-10	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	63256-200-05	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	63256-200-10	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	63256-200-05	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	63256-200-10	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63256-200-05	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63256-200-10	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63256-200-05	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63256-200-10	`e2bbac7714bc…`	`27bdfed8d636…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021388-001	TALC	TALC	5GM/BOT	POWDER / INTRAPLEURAL		RLD, RS	2003-12-15

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021388-001	TALC	5GM/BOT	POWDER / INTRAPLEURAL	RLD, RS	2003-12-15	`e64feba35796…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63256-200-05	2020-01-31	C162847	48780-1	9d75b9d1-1647-f424-e053-dadaa90a57ce	These 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
63256-200-10	2020-01-31	C162847	48780-1	9d75b9d1-1647-f424-e053-dadaa90a57ce	These 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 NDC	Product	Description	Form	Quantity	SPL version
63256-200-05	Sterile Talc	100 mL in 1 BOTTLE	POWDER	100	2
63256-200-05	Sterile Talc	1 in 1 POUCH	POWDER	1	2
63256-200-10	Sterile Talc	100 mL in 1 BOTTLE	POWDER	100	2
63256-200-10	Sterile Talc	10 in 1 BOX	POWDER	10	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63256-200-05	EA - Each	63256-200	bbde1785-4915-40e3-ab37-af52c6be7c13	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Talc	ACTIVE INGREDIENT	7SEV7J4R1U	STERILE TALC (TALC) POWDER [BRYAN CORPORATION]	2
Talc	ACTIVE MOIETY	7SEV7J4R1U	STERILE TALC (TALC) POWDER [BRYAN CORPORATION]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63256-200	STERILE TALC (TALC) POWDER [BRYAN CORPORATION]	2	Legacy NDC, 4 package rows	20141125_72b10d15-8337-49ab-ad8d-0e990192598e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7SEV7J4R1U	TALC	14807-96-6	TALC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
876229	talc 5 GM Intrapleural Powder	PSN	72b10d15-8337-49ab-ad8d-0e990192598e	2
876229	talc 5000 MG Topical Powder	SCD	72b10d15-8337-49ab-ad8d-0e990192598e	2
876229	sterile talc 5 GM Intrapleural Powder	SY	72b10d15-8337-49ab-ad8d-0e990192598e	2
876229	talc 5 GM Intrapleural Powder	SY	72b10d15-8337-49ab-ad8d-0e990192598e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
63256-200-05	63256020005	100 mL in 1 BOTTLE	100 ml	Historical
63256-200-10	63256020010	100 mL in 1 BOTTLE	100 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Talc - Bryan Corporation \| Sciarra Laboratories \| Sciarra Laboratories, Inc.	Bryan Corporation \| Sciarra Laboratories \| Sciarra Laboratories, Inc.	2014-06-05	HUMAN PRESCRIPTION DRUG LABEL	2