CHLORPROMAZINE HCI

Product NDC: 51662-1406
11-digit product format: 516621406
Labeler code: 51662
Product ID: 51662-1406_2b37c8a2-d5d6-015f-e063-6394a90a3899
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CHLORPROMAZINE HCI
Dosage form: INJECTION
Route: INTRAMUSCULAR
Labeler: HF Acquisition Co LLC, DBA HealthFirst
Application: ANDA083329
Marketing category: ANDA
Marketing start: 2019-10-21
Substance: CHLORPROMAZINE HYDROCHLORIDE
Active strength: 25 mg/mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A083329-001	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A083329-001	AP

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A083329-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083329-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083329-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083329-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083329-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083329-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083329-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083329-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083329-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083329-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083329-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083329-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083329-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083329-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083329-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083329-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083329-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083329-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A083329-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083329-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083329-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083329-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083329-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083329-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083329-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083329-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083329-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083329-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083329-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083329-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083329-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A083329-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A083329-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083329-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A083329-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A083329-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A083329-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A083329-001	AP	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLORPROMAZINE HYDROCHLORIDE	25 mg/mL

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
1730076	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
9575c766-3758-6f33-e053-2995a90ae6b1	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
a347b2b0-0f41-4d16-ac0d-358db7d523f1	Product name	1	20220110
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51662-1406-1	CHLORPROMAZINE HCI	2 mL in 1 AMPULE	INJECTION	2		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51662-1406	CHLORPROMAZINE HCI INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]	3	Current NDC, Legacy NDC, 1 package rows	20250110_9575c766-3758-6f33-e053-2995a90ae6b1.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	Henry Schein, Inc.	310d161e-c4db-49e8-8665-d1a6d4e11320	2025-10-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083329 application number: ANDA083329
CHLORPROMAZINE HCI	CHLORPROMAZINE HCI	HF Acquisition Co LLC, DBA HealthFirst	9575c766-3758-6f33-e053-2995a90ae6b1	2025-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083329 application number: ANDA083329 ndc (product): 51662-1406
Chlorpromazine hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	c0f1fcfd-8863-4032-bf80-185df60a4ba0	2024-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083329 application number: ANDA083329

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
1730076	chlorproMAZINE HCl 25 MG in 1 ML Injection	PSN	9575c766-3758-6f33-e053-2995a90ae6b1	3
1730076	1 ML chlorpromazine hydrochloride 25 MG/ML Injection	SCD	9575c766-3758-6f33-e053-2995a90ae6b1	3
1730076	chlorpromazine HCl 25 MG per 1 ML Injection	SY	9575c766-3758-6f33-e053-2995a90ae6b1	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51662-1406-1	51662140601	2 mL in 1 AMPULE (51662-1406-1)	2 ml	2019-10-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CHLORPROMAZINE HCI INJECTION, USP 50 mg/2 mL (25 mg/mL) 2 mL AMPUL	HF Acquisition Co LLC, DBA HealthFirst	2025-01-08	HUMAN PRESCRIPTION DRUG LABEL	3