Chlorpromazine Hydrochloride

Product NDC: 0832-6020
Requested package NDC: 0832-6020-01
11-digit product format: 008326020
Labeler code: 0832
Product ID: 0832-6020_787f32b3-e4f6-424d-a2c0-d249b5bbcd93
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlorpromazine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Upsher-Smith Laboratories, LLC
Application: ANDA084114
Marketing category: ANDA
Marketing start: 2011-08-03
Substance: CHLORPROMAZINE HYDROCHLORIDE
Active strength: 100 mg/1
Pharmacologic classes: Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A084114-001	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	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
A084114-001	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	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084114-001	CHLORPROMAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, RS, 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	A084114-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084114-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084114-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084114-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084114-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084114-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084114-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084114-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084114-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084114-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084114-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084114-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084114-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084114-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084114-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084114-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084114-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084114-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084114-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084114-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084114-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084114-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084114-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084114-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084114-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084114-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084114-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084114-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084114-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084114-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084114-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084114-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084114-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084114-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084114-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084114-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084114-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084114-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084114-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084114-001	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	100 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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
991039	Internal RxNorm lookup
991044	Internal RxNorm lookup
991188	Internal RxNorm lookup
991194	Internal RxNorm lookup
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
5ae79c1e-f523-4358-9f8b-7382a03d59bc	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0832-6020-00	Chlorpromazine Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	4
0832-6020-01	Chlorpromazine Hydrochloride	1 in 1 CARTON	TABLET, FILM COATED	1	4
0832-6020-10	Chlorpromazine Hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	4
0832-6020-89	Chlorpromazine Hydrochloride	100 in 1 BLISTER PACK	TABLET, FILM COATED	100	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0832-6020-00	EA - Each	0832-6020	d5ebe7eb-01f8-4d81-adc4-dd8124ca467a	1	2022-06-06
0832-6020-01	EA - Each	0832-6020	2294e987-29f8-4b21-a78a-4ddeb91d4ffc	1	2022-02-07
0832-6020-10	EA - Each	0832-6020	6027758f-8c27-4132-a2fe-4d300ef7846c	1	2022-06-06
0832-6020-89	EA - Each	0832-6020	d1b91036-04c5-4134-baab-042858add304	1	2022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0832-6020	CHLORPROMAZINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, LLC]	2	Current NDC, Legacy NDC, 4 package rows	20230531_5ae79c1e-f523-4358-9f8b-7382a03d59bc.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	Upsher-Smith Laboratories, LLC	5ae79c1e-f523-4358-9f8b-7382a03d59bc	2026-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084114 application number: ANDA084114 ndc (package): 0832-6020-01 ndc (product): 0832-6020 ndc11 (package): 00832602001
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	REMEDYREPACK INC.	9709ffde-7034-42be-97be-f5f39eeacf72	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084114 application number: ANDA084114

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
991044	chlorproMAZINE HCl 100 MG Oral Tablet	PSN	445baba1-acd8-4010-a8a3-e83e8811ef3f	8
991044	chlorpromazine hydrochloride 100 MG Oral Tablet	SCD	445baba1-acd8-4010-a8a3-e83e8811ef3f	8
991039	chlorproMAZINE HCl 10 MG Oral Tablet	PSN	5ae79c1e-f523-4358-9f8b-7382a03d59bc	4
991044	chlorproMAZINE HCl 100 MG Oral Tablet	PSN	5ae79c1e-f523-4358-9f8b-7382a03d59bc	4
991188	chlorproMAZINE HCl 200 MG Oral Tablet	PSN	5ae79c1e-f523-4358-9f8b-7382a03d59bc	4
991194	chlorproMAZINE HCl 25 MG Oral Tablet	PSN	5ae79c1e-f523-4358-9f8b-7382a03d59bc	4
991336	chlorproMAZINE HCl 50 MG Oral Tablet	PSN	5ae79c1e-f523-4358-9f8b-7382a03d59bc	4
991039	chlorpromazine hydrochloride 10 MG Oral Tablet	SCD	5ae79c1e-f523-4358-9f8b-7382a03d59bc	4
991044	chlorpromazine hydrochloride 100 MG Oral Tablet	SCD	5ae79c1e-f523-4358-9f8b-7382a03d59bc	4
991188	chlorpromazine hydrochloride 200 MG Oral Tablet	SCD	5ae79c1e-f523-4358-9f8b-7382a03d59bc	4
991194	chlorpromazine hydrochloride 25 MG Oral Tablet	SCD	5ae79c1e-f523-4358-9f8b-7382a03d59bc	4
991336	chlorpromazine hydrochloride 50 MG Oral Tablet	SCD	5ae79c1e-f523-4358-9f8b-7382a03d59bc	4
991044	chlorproMAZINE HCl 100 MG Oral Tablet	PSN	9709ffde-7034-42be-97be-f5f39eeacf72	3
991044	chlorpromazine hydrochloride 100 MG Oral Tablet	SCD	9709ffde-7034-42be-97be-f5f39eeacf72	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0832-6020-01	00832602001	1 BLISTER PACK in 1 CARTON (0832-6020-01) / 100 TABLET, FILM COATED in 1 BLISTER PACK (0832-6020-89)	1 blister pack	2021-08-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
chlorproMAZINE Hydrochloride Tablets, USP	Upsher-Smith Laboratories, LLC \| Bora Pharmaceuticals Laboratories Inc.	2026-02-13	HUMAN PRESCRIPTION DRUG LABEL	4
chlorproMAZINE Hydrochloride Tablets, USP	REMEDYREPACK INC.	2025-10-01	HUMAN PRESCRIPTION DRUG LABEL	3
chlorproMAZINE Hydrochloride Tablets, USP	A-S Medication Solutions	2022-07-08	HUMAN PRESCRIPTION DRUG LABEL	8