CHLORPROMAZINE HYDROCHLORIDE

Product NDC: 0904-6894
Requested package NDC: 0904-6894-61
11-digit product format: 009046894
Labeler code: 0904
Product ID: 0904-6894_f0711d3f-c13e-4d83-b92d-1045c1e9cce1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CHLORPROMAZINE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA209755
Marketing category: ANDA
Marketing start: 2018-09-12
Marketing end: 2022-08-31
Substance: CHLORPROMAZINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Phenothiazine [EPC], Phenothiazines [CS]
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	0904-6894	0904-6894-61	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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A209755-001	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-09-10
A209755-002	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2018-09-10
A209755-003	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2018-09-10
A209755-004	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-09-10
A209755-005	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-09-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A209755-001	AB
A209755-002	AB
A209755-003	AB
A209755-004	AB
A209755-005	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 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209755-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209755-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2018-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209755-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2018-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209755-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209755-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-09-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209755-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209755-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2018-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209755-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2018-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209755-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209755-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209755-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209755-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2018-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209755-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2018-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209755-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209755-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209755-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209755-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2018-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209755-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2018-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209755-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209755-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209755-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209755-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2018-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209755-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2018-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209755-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209755-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209755-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209755-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2018-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209755-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2018-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209755-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209755-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209755-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209755-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2018-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209755-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2018-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209755-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209755-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209755-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209755-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2018-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209755-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2018-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209755-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209755-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-09-10	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 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	A209755-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209755-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209755-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209755-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209755-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209755-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209755-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209755-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209755-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209755-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209755-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209755-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209755-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209755-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209755-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209755-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209755-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209755-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209755-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209755-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209755-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209755-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209755-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209755-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209755-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209755-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209755-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209755-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209755-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209755-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209755-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209755-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209755-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209755-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209755-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209755-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209755-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209755-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209755-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209755-005	AB	1	`2680178bc6a6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6894-61	EA - Each	0904-6894	4fd799b4-0c1a-423c-9699-47e3be7f6a9d	1	2019-08-06

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	aa086a21-de85-4b03-af58-49b70acf8cf0	2026-05-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209755 application number: ANDA209755
CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	AvPAK	9e8cebc0-7fcf-dca8-e053-2a95a90a3369	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209755 application number: ANDA209755
CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	American Health Packaging	d43718e5-66d7-44f9-9fc8-80d38d3e41ce	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209755 application number: ANDA209755

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6894-61	00904689461	100 BLISTER PACK in 1 CARTON (0904-6894-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK	100 blister pack	2018-09-12	2022-08-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlorpromazine Hydrochloride Tablets, USP (10 mg, 25 mg, 50 mg, 100 mg & 200 mg) Rx only	Major Pharmaceuticals	2022-07-27	HUMAN PRESCRIPTION DRUG LABEL	5