Chlorpromazine Hydrochloride

Product NDC: 0781-5913
Requested package NDC: 0781-5913-01
11-digit product format: 007815913
Labeler code: 0781
Product ID: 0781-5913_78f4040a-9630-4f29-a2b4-6fc3cbd3b482
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlorpromazine Hydrochloride
Dosage form: TABLET, SUGAR COATED
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA083386
Marketing category: ANDA
Marketing start: 1974-07-09
Marketing end: 2022-12-31
Substance: CHLORPROMAZINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Phenothiazines [CS],Phenothiazine [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0781-5913	0781-5913-01	D	Discontinued by firm		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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-5913-01	EA - Each	0781-5913	d81c403b-7b0a-465b-877b-cc6e9da39a22	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Chlorpromazine Hydrochloride	ACTIVE INGREDIENT	9WP59609J6	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [SANDOZ INC]	5
Chlorpromazine	ACTIVE MOIETY	U42B7VYA4P	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [SANDOZ INC]	5
Acacia	INACTIVE INGREDIENT	5C5403N26O	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [SANDOZ INC]	5
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [SANDOZ INC]	5
Anhydrous Lactose	INACTIVE INGREDIENT	3SY5LH9PMK	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [SANDOZ INC]	5
Calcium Sulfate	INACTIVE INGREDIENT	WAT0DDB505	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [SANDOZ INC]	5
Carnauba Wax	INACTIVE INGREDIENT	R12CBM0EIZ	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [SANDOZ INC]	5
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [SANDOZ INC]	5
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [SANDOZ INC]	5
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [SANDOZ INC]	5
Ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [SANDOZ INC]	5
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [SANDOZ INC]	5
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [SANDOZ INC]	5
Povidones	INACTIVE INGREDIENT	FZ989GH94E	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [SANDOZ INC]	5
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [SANDOZ INC]	5
Shellac	INACTIVE INGREDIENT	46N107B71O	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [SANDOZ INC]	5
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [SANDOZ INC]	5
Sucrose	INACTIVE INGREDIENT	C151H8M554	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [SANDOZ INC]	5
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [SANDOZ INC]	5

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-5913-01	00781591301	100 TABLET, SUGAR COATED in 1 BOTTLE (0781-5913-01)	2017-01-13	2022-12-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
chlorproMAZINE Hydrochloride Tablets, USP	Sandoz Inc \| Upsher-Smith Laboratories,LLC \| Upsher-Smith Laboratories, LLC	2021-07-13	HUMAN PRESCRIPTION DRUG LABEL	16