Chlorpromazine Hydrochloride

Product NDC: 70518-3674
Requested package NDC: 70518-3674-2
11-digit product format: 705183674
Labeler code: 70518
Product ID: 70518-3674_56a5c38b-e6a4-7595-e063-6294a90affe1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlorpromazine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA084113
Marketing category: ANDA
Marketing start: 2023-03-06
Substance: CHLORPROMAZINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Phenothiazine [EPC]; Phenothiazines [CS]
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A084113-001	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, 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
A084113-001	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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084113-001	CHLORPROMAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A084113-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084113-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084113-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084113-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084113-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084113-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084113-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084113-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084113-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084113-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084113-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084113-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084113-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084113-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084113-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084113-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084113-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084113-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084113-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084113-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084113-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084113-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084113-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084113-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084113-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084113-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084113-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084113-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084113-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084113-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084113-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084113-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084113-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084113-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084113-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084113-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084113-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084113-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084113-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084113-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Chlorpromazine Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLORPROMAZINE HYDROCHLORIDE	50 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
41b86f9d-d7e2-4296-8d88-e8257c7cbed2	Available on FDA.report

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3674	CHLORPROMAZINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]	6	Unmatched	20250228_41b86f9d-d7e2-4296-8d88-e8257c7cbed2.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	REMEDYREPACK INC.	41b86f9d-d7e2-4296-8d88-e8257c7cbed2	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084113 application number: ANDA084113 ndc (package): 70518-3674-2 ndc (product): 70518-3674 ndc11 (package): 70518367402
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	5ae79c1e-f523-4358-9f8b-7382a03d59bc	2026-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084113 application number: ANDA084113

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9WP59609J6	CHLORPROMAZINE HYDROCHLORIDE	69-09-0	CHLORPROMAZINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Status
70518-3674-2	70518367402	30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3674-2)	2023-12-04	0	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
chlorproMAZINE Hydrochloride Tablets, USP	REMEDYREPACK INC.	2026-07-15	HUMAN PRESCRIPTION DRUG LABEL	9