Chlorpromazine Hydrochloride

Product NDC: 67046-1633
Requested package NDC: 67046-1633-3
11-digit product format: 670461633
Labeler code: 67046
Product ID: 67046-1633_472ea988-e54b-93cd-e063-6394a90ada7b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlorpromazine Hydrochloride
Dosage form: TABLET, SUGAR COATED
Route: ORAL
Labeler: Coupler LLC
Application: ANDA214827
Marketing category: ANDA
Marketing start: 2025-12-30
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 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214827-001	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2022-01-27
A214827-002	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2022-01-27
A214827-003	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2022-01-27
A214827-004	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2022-01-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A214827-001	AB
A214827-002	AB
A214827-003	AB
A214827-004	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 4 · 128 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
2026-02-19 14:30 UTC	2026-02	A214827-001	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2022-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214827-002	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2022-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214827-003	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2022-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214827-004	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2022-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214827-001	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2022-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214827-002	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2022-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214827-003	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2022-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214827-004	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2022-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214827-001	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2022-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214827-002	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2022-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214827-003	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2022-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214827-004	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2022-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214827-001	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2022-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214827-002	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2022-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214827-003	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2022-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214827-004	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2022-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214827-001	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2022-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214827-002	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2022-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214827-003	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2022-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214827-004	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2022-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214827-001	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2022-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214827-002	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2022-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214827-003	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2022-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214827-004	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2022-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214827-001	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2022-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214827-002	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2022-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214827-003	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2022-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214827-004	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2022-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214827-001	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2022-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214827-002	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2022-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214827-003	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2022-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214827-004	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2022-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214827-001	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2022-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214827-002	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2022-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214827-003	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2022-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214827-004	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2022-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214827-001	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2022-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214827-002	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2022-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214827-003	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2022-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214827-004	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2022-01-27	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 128 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214827-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214827-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214827-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214827-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214827-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214827-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214827-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214827-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214827-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214827-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214827-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214827-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214827-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214827-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214827-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214827-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214827-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214827-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214827-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214827-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214827-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214827-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214827-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214827-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214827-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214827-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214827-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214827-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214827-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214827-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214827-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214827-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214827-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214827-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214827-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214827-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214827-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214827-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214827-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214827-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Chlorpromazine Hydrochloride
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
991194	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
472e9a45-4060-3b2a-e063-6294a90a716a	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	Strength	SPL version
67046-1633-3	Chlorpromazine Hydrochloride	30 in 1 BLISTER PACK	TABLET, SUGAR COATED	30		1

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	American Health Packaging	85ab0b93-c716-4889-87db-9e76e75df7c7	2026-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214827 application number: ANDA214827
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	REMEDYREPACK INC.	d3b09b67-e8da-450d-8a52-b3c40605de26	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214827 application number: ANDA214827
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	REMEDYREPACK INC.	b8137906-946c-455d-87c0-0e130cd9266f	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214827 application number: ANDA214827
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	REMEDYREPACK INC.	2122d619-3f5b-48f6-8f0b-7693199abbdb	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214827 application number: ANDA214827
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	REMEDYREPACK INC.	c2a38be8-43e6-4a56-9556-fe3dad412b82	2026-02-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214827 application number: ANDA214827
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Coupler LLC	472e9a45-4060-3b2a-e063-6294a90a716a	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214827 application number: ANDA214827 ndc (package): 67046-1633-3 ndc (product): 67046-1633 ndc11 (package): 67046163303
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Coupler LLC	35a743a1-5354-2c50-e063-6394a90a15f9	2025-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214827 application number: ANDA214827
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Novadoz Pharmaceuticals LLC	315ce03f-d9f8-4f3a-9e83-922747430c23	2022-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214827 application number: ANDA214827

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
991194	chlorproMAZINE HCl 25 MG Oral Tablet	PSN	472e9a45-4060-3b2a-e063-6294a90a716a	1
991194	chlorpromazine hydrochloride 25 MG Oral Tablet	SCD	472e9a45-4060-3b2a-e063-6294a90a716a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
67046-1633-3	67046163303	30 TABLET, SUGAR COATED in 1 BLISTER PACK (67046-1633-3)	2025-12-30	No	No	Current