ChlorproMAZINE Hydrochloride

Product NDC: 63304-122
Requested package NDC: 63304-122-01
11-digit product format: 633040122
Labeler code: 63304
Product ID: 63304-122_c2d3824b-8e6f-414d-aa16-de9e2d448645
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ChlorproMAZINE
Dosage form: TABLET, SUGAR COATED
Route: ORAL
Labeler: Sun Pharmaceutical Industries Inc
Application: ANDA214256
Marketing category: ANDA
Marketing start: 2020-11-18
Marketing end: 0000-00-00
Substance: CHLORPROMAZINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	63304-122	63304-122-01	D	Discontinued by firm		2026-11-13

Source provenance: Browse the complete Orange Book source catalog · source snapshot 45.

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	Approval date
A214256-001	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2020-10-26
A214256-002	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2020-10-26
A214256-003	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2020-10-26
A214256-004	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2020-10-26
A214256-005	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	2020-10-26

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 5 · 200 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
2026-11-14 07:37:17	2026-10	A214256-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2020-10-26	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A214256-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2020-10-26	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A214256-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL		2020-10-26	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A214256-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL		2020-10-26	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A214256-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL		2020-10-26	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	A214256-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2020-10-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214256-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2020-10-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214256-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL		2020-10-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214256-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL		2020-10-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214256-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL		2020-10-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A214256-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2020-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214256-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2020-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214256-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL		2020-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214256-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL		2020-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214256-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL		2020-10-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214256-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2020-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214256-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2020-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214256-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL		2020-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214256-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL		2020-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214256-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL		2020-10-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214256-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2020-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214256-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2020-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214256-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL		2020-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214256-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL		2020-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214256-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL		2020-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214256-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2020-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214256-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2020-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214256-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL		2020-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214256-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL		2020-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214256-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL		2020-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214256-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2020-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214256-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2020-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214256-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL		2020-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214256-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL		2020-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214256-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL		2020-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214256-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214256-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214256-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214256-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214256-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-10-26	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 160 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214256-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214256-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214256-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214256-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214256-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214256-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214256-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214256-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214256-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214256-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214256-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214256-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214256-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214256-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214256-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214256-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214256-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214256-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214256-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214256-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214256-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214256-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214256-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214256-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214256-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214256-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214256-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214256-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214256-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214256-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214256-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214256-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214256-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214256-004	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214256-005	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214256-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214256-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214256-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214256-004	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214256-005	AB	1	`79d66fd596c7…`

Reported adverse events (FAERS/openFDA)#

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

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
a347b2b0-0f41-4d16-ac0d-358db7d523f1	Product name	1	20220110

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63304-122-01	ChlorproMAZINE Hydrochloride	100 in 1 BOTTLE	TABLET, SUGAR COATED	100		6
63304-122-10	ChlorproMAZINE Hydrochloride	1000 in 1 BOTTLE	TABLET, SUGAR COATED	1000		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63304-122-01	EA - Each	63304-122	6505351d-0387-4540-b0d5-565d18613cfe	1	2021-04-08
63304-122-10	EA - Each	63304-122	6cd80c7c-8e7f-4297-98c5-16c7cb21e8a7	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63304-122	CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE) TABLET, SUGAR COATED [SUN PHARMACEUTICAL INDUSTRIES INC]	6	Legacy NDC, 2 package rows	20220119_432cd4ca-c728-48ff-beec-2485f5e02512.zip

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	432cd4ca-c728-48ff-beec-2485f5e02512	6
991044	chlorproMAZINE HCl 100 MG Oral Tablet	PSN	432cd4ca-c728-48ff-beec-2485f5e02512	6
991188	chlorproMAZINE HCl 200 MG Oral Tablet	PSN	432cd4ca-c728-48ff-beec-2485f5e02512	6
991194	chlorproMAZINE HCl 25 MG Oral Tablet	PSN	432cd4ca-c728-48ff-beec-2485f5e02512	6
991336	chlorproMAZINE HCl 50 MG Oral Tablet	PSN	432cd4ca-c728-48ff-beec-2485f5e02512	6
991039	chlorpromazine hydrochloride 10 MG Oral Tablet	SCD	432cd4ca-c728-48ff-beec-2485f5e02512	6
991044	chlorpromazine hydrochloride 100 MG Oral Tablet	SCD	432cd4ca-c728-48ff-beec-2485f5e02512	6
991188	chlorpromazine hydrochloride 200 MG Oral Tablet	SCD	432cd4ca-c728-48ff-beec-2485f5e02512	6
991194	chlorpromazine hydrochloride 25 MG Oral Tablet	SCD	432cd4ca-c728-48ff-beec-2485f5e02512	6
991336	chlorpromazine hydrochloride 50 MG Oral Tablet	SCD	432cd4ca-c728-48ff-beec-2485f5e02512	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63304-122-01	63304012201	100 TABLET, SUGAR COATED in 1 BOTTLE (63304-122-01)	2020-11-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ChlorproMAZINE Hydrochloride Tablets, USP	Sun Pharmaceutical Industries Inc \| Aizant Drug Research Solutions Pvt. Ltd.	2026-06-04	HUMAN PRESCRIPTION DRUG LABEL	7