CHLORPROMAZINE HCI

Product NDC: 43598-140
11-digit product format: 435980140
Labeler code: 43598
Product ID: 43598-140_910baac6-1b03-7055-e946-0b4b1b1f043f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CHLORPROMAZINE HCI
Dosage form: INJECTION
Route: INTRAMUSCULAR
Labeler: Dr. Reddy's Laboratories Inc.,
Application: ANDA080365
Marketing category: ANDA
Marketing start: 2024-09-04
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
A080365-001	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	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
A080365-001	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	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080365-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		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	A080365-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080365-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080365-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080365-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080365-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080365-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080365-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080365-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080365-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080365-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080365-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080365-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080365-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080365-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080365-001	AP	1	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080365-001	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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1730076	Internal RxNorm lookup
1730078	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
1ec15bce-8a50-9c9a-419a-11b9d58dc5b8	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
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
a347b2b0-0f41-4d16-ac0d-358db7d523f1	Product name	1	20220110
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43598-140-11	CHLORPROMAZINE HCI	1 mL in 1 VIAL	INJECTION	1		4
43598-140-25	CHLORPROMAZINE HCI	25 in 1 CARTON	INJECTION	25		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43598-140-11	ML - Milliliter	43598-140	2920a435-11ff-4f4c-8e30-8db0e44cc7e1	1	2024-09-09
43598-140-25	ML - Milliliter	43598-140	7f75929e-03be-4f34-aae3-b9550ed7be6d	1	2024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-140	CHLORPROMAZINE HCI INJECTION [DR. REDDY'S LABORATORIES INC.,]	4	Current NDC, 2 package rows	20240926_1ec15bce-8a50-9c9a-419a-11b9d58dc5b8.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHLORPROMAZINE HCI	CHLORPROMAZINE HCI	Dr. Reddy's Laboratories Inc.,	1ec15bce-8a50-9c9a-419a-11b9d58dc5b8	2023-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080365 application number: ANDA080365 ndc (product): 43598-140

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	1ec15bce-8a50-9c9a-419a-11b9d58dc5b8	4
1730078	chlorproMAZINE HCl 50 MG in 2 ML Injection	PSN	1ec15bce-8a50-9c9a-419a-11b9d58dc5b8	4
1730076	1 ML chlorpromazine hydrochloride 25 MG/ML Injection	SCD	1ec15bce-8a50-9c9a-419a-11b9d58dc5b8	4
1730078	2 ML chlorpromazine hydrochloride 25 MG/ML Injection	SCD	1ec15bce-8a50-9c9a-419a-11b9d58dc5b8	4
1730076	chlorpromazine HCl 25 MG per 1 ML Injection	SY	1ec15bce-8a50-9c9a-419a-11b9d58dc5b8	4
1730078	chlorpromazine HCl 50 MG per 2 ML Injection	SY	1ec15bce-8a50-9c9a-419a-11b9d58dc5b8	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
43598-140-11	43598014011	1 mL in 1 VIAL	1 ml				Historical
43598-140-25	43598014025	25 VIAL in 1 CARTON (43598-140-25) / 1 mL in 1 VIAL (43598-140-11)	25 vial	2024-09-04	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)	Dr. Reddy's Laboratories Inc., \| Dr. Reddy's Laboratories Limited-9	2023-03-09	HUMAN PRESCRIPTION DRUG LABEL	4