Chlorpromazine

Product NDC: 70518-4724
11-digit product format: 705184724
Labeler code: 70518
Product ID: 70518-4724_5967410b-42bc-7c9f-e063-6394a90a91eb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlorpromazine
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA217350
Marketing category: ANDA
Marketing start: 2026-08-11
Substance: CHLORPROMAZINE HYDROCHLORIDE
Active strength: 100 mg/1
Pharmacologic classes: Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A217350-001	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-07-18
A217350-002	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2023-07-18
A217350-003	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2023-07-18
A217350-004	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-07-18
A217350-005	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2023-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217350-001	AB
A217350-002	AB
A217350-003	AB
A217350-004	AB
A217350-005	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 3 · 110 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
2026-09-14 22:38:34	2026-08	A217350-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-07-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217350-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2023-07-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217350-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2023-07-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217350-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-07-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217350-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2023-07-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217350-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217350-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2023-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217350-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2023-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217350-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217350-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2023-07-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217350-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217350-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2023-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217350-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2023-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217350-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217350-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2023-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217350-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217350-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2023-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217350-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2023-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217350-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217350-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2023-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217350-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217350-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2023-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217350-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2023-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217350-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217350-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2023-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217350-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217350-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2023-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217350-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2023-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217350-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217350-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2023-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217350-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217350-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2023-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217350-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2023-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217350-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217350-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2023-07-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217350-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217350-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2023-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217350-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2023-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217350-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217350-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2023-07-18	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 110 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217350-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217350-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217350-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217350-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217350-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217350-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217350-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217350-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217350-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217350-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217350-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217350-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217350-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217350-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217350-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217350-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217350-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217350-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217350-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217350-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217350-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217350-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217350-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217350-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217350-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217350-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217350-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217350-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217350-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217350-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217350-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217350-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217350-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217350-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217350-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217350-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217350-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217350-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217350-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217350-005	AB	1	`03ed91905a0d…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Chlorpromazine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLORPROMAZINE HYDROCHLORIDE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9WP59609J6	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
991044	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
0dc38655-01b1-413e-9139-2466014cb4d0	Available on FDA.report

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	CHLORPROMAZINE	REMEDYREPACK INC.	0dc38655-01b1-413e-9139-2466014cb4d0	2026-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217350 application number: ANDA217350 ndc (product): 70518-4724
Chlorpromazine	CHLORPROMAZINE	Alembic Pharmaceuticals Inc.	4a0b3268-1d5a-4c98-af77-2461fb488476	2024-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217350 application number: ANDA217350
Chlorpromazine	CHLORPROMAZINE	Alembic Pharmaceuticals Limited	1f9751ff-33da-44be-9c1f-9bbf88ac543b	2023-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217350 application number: ANDA217350

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9WP59609J6	CHLORPROMAZINE HYDROCHLORIDE	69-09-0	CHLORPROMAZINE HYDROCHLORIDE
U42B7VYA4P	CHLORPROMAZINE	50-53-3	Chlorpromazine

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4724-0	70518472400	100 POUCH in 1 BOX (70518-4724-0) / 1 TABLET in 1 POUCH (70518-4724-1)	100 pouch	2026-08-11	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlorpromazine Hydrochloride Tablets, USP Rx only	REMEDYREPACK INC.	2026-08-19	HUMAN PRESCRIPTION DRUG LABEL	1