Chlorpromazine

Product NDC: 46708-736
11-digit product format: 467080736
Labeler code: 46708
Product ID: 46708-736_1f9751ff-33da-44be-9c1f-9bbf88ac543b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlorpromazine
Dosage form: TABLET
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA217350
Marketing category: ANDA
Marketing start: 2023-07-20
Substance: CHLORPROMAZINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
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 · 105 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	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…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217350-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217350-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2023-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217350-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2023-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217350-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217350-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2023-07-18	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 105 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	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…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217350-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217350-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217350-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217350-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217350-005	AB	1	`2680178bc6a6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Chlorpromazine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLORPROMAZINE HYDROCHLORIDE	25 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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
991039	Internal RxNorm lookup
991044	Internal RxNorm lookup
991188	Internal RxNorm lookup
991194	Internal RxNorm lookup
991336	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
1f9751ff-33da-44be-9c1f-9bbf88ac543b	Available on FDA.report

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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
a347b2b0-0f41-4d16-ac0d-358db7d523f1	Product name	1	20220110
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
46708-736-10	Chlorpromazine	10 in 1 BLISTER PACK	TABLET	10	1
46708-736-10	Chlorpromazine	100 in 1 CARTON	TABLET	100	1
46708-736-31	Chlorpromazine	100 in 1 BOTTLE	TABLET	100	1
46708-736-91	Chlorpromazine	1000 in 1 BOTTLE	TABLET	1000	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-736	CHLORPROMAZINE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]	1	Current NDC, 4 package rows	20230726_1f9751ff-33da-44be-9c1f-9bbf88ac543b.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 ndc (product): 46708-736

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
991039	chlorproMAZINE HCl 10 MG Oral Tablet	PSN	1f9751ff-33da-44be-9c1f-9bbf88ac543b	1
991044	chlorproMAZINE HCl 100 MG Oral Tablet	PSN	1f9751ff-33da-44be-9c1f-9bbf88ac543b	1
991188	chlorproMAZINE HCl 200 MG Oral Tablet	PSN	1f9751ff-33da-44be-9c1f-9bbf88ac543b	1
991194	chlorproMAZINE HCl 25 MG Oral Tablet	PSN	1f9751ff-33da-44be-9c1f-9bbf88ac543b	1
991336	chlorproMAZINE HCl 50 MG Oral Tablet	PSN	1f9751ff-33da-44be-9c1f-9bbf88ac543b	1
991039	chlorpromazine hydrochloride 10 MG Oral Tablet	SCD	1f9751ff-33da-44be-9c1f-9bbf88ac543b	1
991044	chlorpromazine hydrochloride 100 MG Oral Tablet	SCD	1f9751ff-33da-44be-9c1f-9bbf88ac543b	1
991188	chlorpromazine hydrochloride 200 MG Oral Tablet	SCD	1f9751ff-33da-44be-9c1f-9bbf88ac543b	1
991194	chlorpromazine hydrochloride 25 MG Oral Tablet	SCD	1f9751ff-33da-44be-9c1f-9bbf88ac543b	1
991336	chlorpromazine hydrochloride 50 MG Oral Tablet	SCD	1f9751ff-33da-44be-9c1f-9bbf88ac543b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
46708-736-10	46708073610	100 BLISTER PACK in 1 CARTON (46708-736-10) / 10 TABLET in 1 BLISTER PACK	100 blister pack	2023-07-20	No	No	Current
46708-736-31	46708073631	100 TABLET in 1 BOTTLE (46708-736-31)	100 tablet	2023-07-20	No	No	Current
46708-736-91	46708073691	1000 TABLET in 1 BOTTLE (46708-736-91)	1000 tablet	2023-07-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlorpromazine Hydrochloride Tablets, USP Rx only	Alembic Pharmaceuticals Limited	2023-07-24	Human Prescription Drug Label	1