Chlorpromazine hydrochloride

Product NDC: 70771-1509
11-digit product format: 707711509
Labeler code: 70771
Product ID: 70771-1509_bea6994f-8f72-4c2d-8ba3-c74b10f8412d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlorpromazine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: ANDA213368
Marketing category: ANDA
Marketing start: 2020-01-27
Substance: CHLORPROMAZINE HYDROCHLORIDE
Active strength: 100 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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A213368-001	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-01-17
A213368-002	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-01-17
A213368-003	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-01-17
A213368-004	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-01-17
A213368-005	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-01-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213368-001	AB
A213368-002	AB
A213368-003	AB
A213368-004	AB
A213368-005	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 5 · 185 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	A213368-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213368-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213368-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213368-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213368-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-01-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213368-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213368-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213368-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213368-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213368-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-01-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213368-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213368-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213368-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213368-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213368-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-01-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213368-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213368-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213368-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213368-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213368-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-01-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213368-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213368-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213368-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213368-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213368-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-01-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213368-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213368-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213368-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213368-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213368-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-01-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213368-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213368-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213368-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213368-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213368-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-01-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213368-001	CHLORPROMAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213368-002	CHLORPROMAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213368-003	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213368-004	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213368-005	CHLORPROMAZINE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-01-17	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 185 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	A213368-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213368-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213368-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213368-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213368-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213368-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213368-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213368-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213368-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213368-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213368-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213368-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213368-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213368-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213368-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213368-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213368-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213368-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213368-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213368-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213368-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213368-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213368-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213368-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213368-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213368-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213368-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213368-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213368-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213368-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213368-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213368-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213368-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213368-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213368-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213368-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213368-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213368-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213368-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213368-005	AB	1	`5bbf6a4d5a75…`

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	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 · 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
0ea5e0c6-0062-4be3-96f2-62397da3e77d	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
a347b2b0-0f41-4d16-ac0d-358db7d523f1	Product name	1	20220110

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70771-1509-1	Chlorpromazine hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	4
70771-1509-2	Chlorpromazine hydrochloride	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	4
70771-1509-4	Chlorpromazine hydrochloride	10 in 1 CARTON	TABLET, FILM COATED	10	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1509	CHLORPROMAZINE HYDROCHLORIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	4	Current NDC, Legacy NDC, 3 package rows	20240606_0ea5e0c6-0062-4be3-96f2-62397da3e77d.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorpromazine hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Northstar Rx LLC	2bd42d3a-bf89-4d74-a252-9b914106a570	2025-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213368 application number: ANDA213368
Chlorpromazine hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	fc2bd95d-a7bc-4ab5-bffa-f5059cb8eb63	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213368 application number: ANDA213368
Chlorpromazine hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Zydus Lifesciences Limited	0ea5e0c6-0062-4be3-96f2-62397da3e77d	2024-06-04		Exact identifier application applno (ANDA): 213368 application number: ANDA213368 ndc (product): 70771-1509

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
991039	chlorproMAZINE HCl 10 MG Oral Tablet	PSN	0ea5e0c6-0062-4be3-96f2-62397da3e77d	4
991044	chlorproMAZINE HCl 100 MG Oral Tablet	PSN	0ea5e0c6-0062-4be3-96f2-62397da3e77d	4
991188	chlorproMAZINE HCl 200 MG Oral Tablet	PSN	0ea5e0c6-0062-4be3-96f2-62397da3e77d	4
991194	chlorproMAZINE HCl 25 MG Oral Tablet	PSN	0ea5e0c6-0062-4be3-96f2-62397da3e77d	4
991336	chlorproMAZINE HCl 50 MG Oral Tablet	PSN	0ea5e0c6-0062-4be3-96f2-62397da3e77d	4
991039	chlorpromazine hydrochloride 10 MG Oral Tablet	SCD	0ea5e0c6-0062-4be3-96f2-62397da3e77d	4
991044	chlorpromazine hydrochloride 100 MG Oral Tablet	SCD	0ea5e0c6-0062-4be3-96f2-62397da3e77d	4
991188	chlorpromazine hydrochloride 200 MG Oral Tablet	SCD	0ea5e0c6-0062-4be3-96f2-62397da3e77d	4
991194	chlorpromazine hydrochloride 25 MG Oral Tablet	SCD	0ea5e0c6-0062-4be3-96f2-62397da3e77d	4
991336	chlorpromazine hydrochloride 50 MG Oral Tablet	SCD	0ea5e0c6-0062-4be3-96f2-62397da3e77d	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70771-1509-1	70771150901	100 TABLET, FILM COATED in 1 BOTTLE (70771-1509-1)		2020-01-27	0000-00-00	Yes	No	Current
70771-1509-2	70771150902	10 in 1 BLISTER PACK						Historical
70771-1509-4	70771150904	10 BLISTER PACK in 1 CARTON (70771-1509-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1509-2)	10 blister pack	2020-01-27	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
chlorproMAZINE Hydrochloride Tablets, USP Rx only	Zydus Lifesciences Limited	2024-06-04	HUMAN PRESCRIPTION DRUG LABEL	4