chlorpromazine hydrochloride

Product NDC: 53808-0928
11-digit product format: 538080928
Labeler code: 53808
Product ID: 53808-0928_30f99c0e-3a3b-44a9-8a4c-89a3e88d665c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CHLORPROMAZINE HYDROCHLORIDE
Dosage form: TABLET, SUGAR COATED
Route: ORAL
Labeler: State of Florida DOH Central Pharmacy
Application: ANDA083386
Marketing category: ANDA
Marketing start: 2009-07-01
Marketing end: 0000-00-00
Substance: CHLORPROMAZINE HYDROCHLORIDE
Active strength: 100 mg/1
Pharmacologic classes: Phenothiazines [CS],Phenothiazine [EPC]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53808-0928		I	Inactivated by FDA		2026-08-17
excluded package	package	53808-0928	53808-0928-1	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 1 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53808-0928-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53808-0928-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53808-0928-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53808-0928-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53808-0928-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53808-0928-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53808-0928-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53808-0928-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53808-0928-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53808-0928-1	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53808-0928-1	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53808-0928-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53808-0928-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53808-0928-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53808-0928-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53808-0928-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53808-0928-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53808-0928-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53808-0928-1	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53808-0928-1	E	Excluded after deficient or non-compliant submission was not corrected	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53808-0928-1	E	Excluded after deficient or non-compliant submission was not corrected	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53808-0928-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A083386-001	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A083386-001	AB

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	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A083386-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A083386-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083386-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083386-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083386-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083386-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083386-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083386-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083386-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083386-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083386-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083386-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083386-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083386-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083386-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083386-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083386-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083386-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083386-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083386-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083386-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083386-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083386-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083386-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083386-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083386-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083386-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083386-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083386-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083386-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083386-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083386-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083386-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083386-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083386-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083386-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A083386-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A083386-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083386-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A083386-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A083386-001	AB	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4907e598-fa92-6444-8b2a-22992506f30a	Product name	7	20260202
78470689-2901-bec5-3fa3-182378bb1540	Product name	3	20250124
a347b2b0-0f41-4d16-ac0d-358db7d523f1	Product name	1	20220110

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-0928-1	2021-01-29	C162847	48780-1	956f9ecf-dea5-621f-e053-dbdaa90a74ad	Chlorpromazine Hydrochloride Tablets, USP 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-0928-1	chlorpromazine hydrochloride	30 in 1 BLISTER PACK	TABLET, SUGAR COATED	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHLORPROMAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	9WP59609J6	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CHLORPROMAZINE	ACTIVE MOIETY	U42B7VYA4P	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ACACIA	INACTIVE INGREDIENT	5C5403N26O	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-0928	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1	Legacy NDC, 1 package rows	20100611_33c01749-ef88-4e9c-8b45-0f026af1d5fd.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	5ae79c1e-f523-4358-9f8b-7382a03d59bc	2026-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083386 application number: ANDA083386

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9WP59609J6	CHLORPROMAZINE HYDROCHLORIDE	69-09-0	CHLORPROMAZINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
991044	chlorproMAZINE HCl 100 MG Oral Tablet	PSN	33c01749-ef88-4e9c-8b45-0f026af1d5fd	1
991188	chlorproMAZINE HCl 200 MG Oral Tablet	PSN	33c01749-ef88-4e9c-8b45-0f026af1d5fd	1
991194	chlorproMAZINE HCl 25 MG Oral Tablet	PSN	33c01749-ef88-4e9c-8b45-0f026af1d5fd	1
991336	chlorproMAZINE HCl 50 MG Oral Tablet	PSN	33c01749-ef88-4e9c-8b45-0f026af1d5fd	1
991044	chlorpromazine hydrochloride 100 MG Oral Tablet	SCD	33c01749-ef88-4e9c-8b45-0f026af1d5fd	1
991188	chlorpromazine hydrochloride 200 MG Oral Tablet	SCD	33c01749-ef88-4e9c-8b45-0f026af1d5fd	1
991194	chlorpromazine hydrochloride 25 MG Oral Tablet	SCD	33c01749-ef88-4e9c-8b45-0f026af1d5fd	1
991336	chlorpromazine hydrochloride 50 MG Oral Tablet	SCD	33c01749-ef88-4e9c-8b45-0f026af1d5fd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53808-0928-1	53808092801	30 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlorpromazine Hydrochloride Tablets, USP 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg	State of Florida DOH Central Pharmacy	2010-05-21	HUMAN PRESCRIPTION DRUG LABEL	1