Home NDC 0781-4028 Chlorpromazine Hydrochloride
Product NDC 0781-4028
11-digit product format 007814028
Labeler code 0781
Product ID 0781-4028_cfff95df-4926-4139-a109-2beebebcf014
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Chlorpromazine Hydrochloride
Dosage form CONCENTRATE
Route ORAL
Labeler Sandoz, Inc.
Application ANDA214542
Marketing category ANDA
Marketing start 2023-03-31
Substance CHLORPROMAZINE HYDROCHLORIDE
Active strength 100 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214542-001 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL AA RS 2021-06-02 A214542-002 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL AA RS 2021-06-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 68 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL AA RS 2021-06-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL AA RS 2021-06-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL AB RS 2021-06-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL AB RS 2021-06-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL AB RS 2021-06-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL AB RS 2021-06-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 782e0a99824c…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# 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 100 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 991053 Internal RxNorm lookup 991332 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0781-4028-22 Chlorpromazine Hydrochloride 240 mL in 1 BOTTLE, PLASTIC CONCENTRATE 240 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-4028 CHLORPROMAZINE HYDROCHLORIDE CONCENTRATE [SANDOZ, INC.] 2 Current NDC, 1 package rows 20230404_9398a0b4-e08b-4eb7-9f31-97d4f384427a.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0781-4028-22 00781402822 240 mL in 1 BOTTLE, PLASTIC (0781-4028-22) 240 ml 2023-03-31 No No Current