CHLORPROMAZINE HYDROCHLORIDE

Product NDC: 55150-319
11-digit product format: 551500319
Labeler code: 55150
Product ID: 55150-319_de29daf4-7c8a-4b37-b33c-e9f34f3a14c7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CHLORPROMAZINE HYDROCHLORIDE
Dosage form: INJECTION
Route: INTRAMUSCULAR
Labeler: Eugia US LLC
Application: ANDA211816
Marketing category: ANDA
Marketing start: 2020-07-07
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
A211816-001	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP		2020-07-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211816-001	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
2026-08-18 06:07:40	2026-07	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211816-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	2020-07-07	`a50c72e98297…`

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	A211816-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211816-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211816-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211816-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211816-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211816-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211816-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211816-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211816-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211816-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211816-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211816-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211816-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211816-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211816-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211816-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211816-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211816-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211816-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211816-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211816-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211816-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211816-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211816-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211816-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211816-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211816-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211816-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211816-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211816-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211816-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211816-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211816-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211816-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211816-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211816-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211816-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211816-001	AP	1	`a50c72e98297…`

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	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
07e6144a-b460-4887-b8e2-dd371c14a55c	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
55150-319-01	CHLORPROMAZINE HYDROCHLORIDE	2 mL in 1 AMPULE	INJECTION	2		7
55150-319-25	CHLORPROMAZINE HYDROCHLORIDE	25 in 1 CARTON	INJECTION	25		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55150-319	CHLORPROMAZINE HYDROCHLORIDE INJECTION [EUGIA US LLC]	4	Current NDC, Legacy NDC, 2 package rows	20240727_07e6144a-b460-4887-b8e2-dd371c14a55c.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 HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	Eugia US LLC	07e6144a-b460-4887-b8e2-dd371c14a55c	2025-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211816 application number: ANDA211816 ndc (product): 55150-319

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	07e6144a-b460-4887-b8e2-dd371c14a55c	7
1730078	chlorproMAZINE HCl 50 MG in 2 ML Injection	PSN	07e6144a-b460-4887-b8e2-dd371c14a55c	7
1730076	1 ML chlorpromazine hydrochloride 25 MG/ML Injection	SCD	07e6144a-b460-4887-b8e2-dd371c14a55c	7
1730078	2 ML chlorpromazine hydrochloride 25 MG/ML Injection	SCD	07e6144a-b460-4887-b8e2-dd371c14a55c	7
1730076	chlorpromazine HCl 25 MG per 1 ML Injection	SY	07e6144a-b460-4887-b8e2-dd371c14a55c	7
1730078	chlorpromazine HCl 50 MG per 2 ML Injection	SY	07e6144a-b460-4887-b8e2-dd371c14a55c	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55150-319-01	55150031901	2 mL in 1 AMPULE	2 ml					Historical
55150-319-25	55150031925	25 AMPULE in 1 CARTON (55150-319-25) / 2 mL in 1 AMPULE (55150-319-01)	25 ampule	2020-07-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlorpromazine Hydrochloride Injection, USP Rx only	Eugia US LLC \| EUGIA PHARMA SPECIALITIES LIMITED \| Eugia Steriles Private Limited	2025-12-09	Human Prescription Drug Label	7