Chlorpromazine Hydrochloride Injection, USP

Manufacturer: Zydus Lifesciences Limited | Zydus Pharmaceuticals USA Inc.
Effective date: 2025-11-04
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:04:08

Label at a glance#

ProductChlorpromazine Hydrochloride

Active ingredientCHLORPROMAZINE HYDROCHLORIDE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1778-1

chlorproMAZINE Hydrochloride Injection, USP

25 mg/mL

For Deep Intramuscular Use

Discard unused portion

1 mL Single-Dose Vial

Rx only

NDC 70771-1778-7

chlorproMAZINE Hydrochloride Injection, USP

25 mg/mL

For Deep Intramuscular Use

Discard unused portion

25 x 1 mL Single-Dose Vial

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1730076	chlorproMAZINE HCl 25 MG in 1 ML Injection	PSN	2
1730078	chlorproMAZINE HCl 50 MG in 2 ML Injection	PSN	2
1730076	1 ML chlorpromazine hydrochloride 25 MG/ML Injection	SCD	2
1730078	2 ML chlorpromazine hydrochloride 25 MG/ML Injection	SCD	2
1730076	chlorpromazine HCl 25 MG per 1 ML Injection	SY	2
1730078	chlorpromazine HCl 50 MG per 2 ML Injection	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CHLORPROMAZINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	DataBar Omni	(01)00370710184919	GTIN-14: 00370710184919 GTIN-12: 370710184919 UPC-A: 370710184919 EAN-13: 0370710184919 GTIN storage (14 digits): 00370710184919	bcbd52b5-2981-407b-b260-0568efab3890-01.jpg

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	SPL version
70771-1778-1	Chlorpromazine Hydrochloride	1 mL in 1 VIAL	INJECTION	1	2
70771-1778-7	Chlorpromazine Hydrochloride	25 in 1 CARTON	INJECTION	25	2
70771-1779-1	Chlorpromazine Hydrochloride	2 mL in 1 VIAL	INJECTION	2	2
70771-1779-7	Chlorpromazine Hydrochloride	25 in 1 CARTON	INJECTION	25	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

Chlorpromazine Hydrochloride
CHLORPROMAZINE
ASCORBIC ACID
SODIUM METABISULFITE
SODIUM SULFITE
SODIUM CHLORIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1778	70771-1778-1, 70771-1778-7
70771-1779	70771-1779-1, 70771-1779-7

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CHLORPROMAZINE HYDROCHLORIDE	9WP59609J6	ACTIB
ASCORBIC ACID	PQ6CK8PD0R	IACT
SODIUM METABISULFITE	4VON5FNS3C	IACT
SODIUM SULFITE	VTK01UQK3G	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
WATER	059QF0KO0R	IACT
CHLORPROMAZINE HYDROCHLORIDE	9WP59609J6	ACTIB
ASCORBIC ACID	PQ6CK8PD0R	IACT
SODIUM METABISULFITE	4VON5FNS3C	IACT
SODIUM SULFITE	VTK01UQK3G	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
1	2024-03-14	full-release	2026-05-31 21:01:29

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A217275-001	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP		2024-03-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217275-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A217275-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2024-03-13	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A217275-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2024-03-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217275-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2024-03-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217275-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2024-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217275-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2024-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217275-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2024-03-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217275-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2024-03-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217275-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2024-03-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217275-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2024-03-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217275-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2024-03-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217275-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2024-03-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217275-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2024-03-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217275-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2024-03-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217275-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2024-03-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217275-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2024-03-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217275-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2024-03-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217275-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2024-03-13	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217275-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2024-03-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A217275-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A217275-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217275-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217275-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217275-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217275-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217275-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217275-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217275-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217275-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217275-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217275-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217275-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217275-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217275-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217275-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217275-001	AP	1	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217275-001	AP	1	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Zydus Lifesciences Limited	d37a4c21-b503-4791-a4d0-2ccc8891d88e	2025-11-04		Exact identifier ndc (package): 70771-1778-1 ndc (package): 70771-1779-7 ndc (package): 70771-1778-7 ndc (package): 70771-1779-1 ndc (product): 70771-1778 ndc (product): 70771-1779 ndc11 (package): 70771177901 ndc11 (package): 70771177801 ndc11 (package): 70771177807 ndc11 (package): 70771177907 spl id: bdfa9437-bd3f-496f-a640-753422d69c85 spl set id: d37a4c21-b503-4791-a4d0-2ccc8891d88e

Reported adverse events (FAERS/openFDA)#

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