Home NDC 24338-403-12 Chlorpromazine Hydrochloride
Product NDC 24338-403
Requested package NDC 24338-403-12
11-digit product format 243380403
Labeler code 24338
Product ID 24338-403_d3c3c2cc-ad9e-436a-a044-555b3544c202
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Chlorpromazine Hydrochloride
Dosage form CONCENTRATE
Route ORAL
Labeler Azurity Pharmaceuticals, Inc.
Application ANDA214542
Marketing category ANDA
Marketing start 2021-08-02
Marketing end 0000-00-00
Substance CHLORPROMAZINE HYDROCHLORIDE
Active strength 30 mg/mL
Pharmacologic classes Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag No
Listing certified through 2024-12-31
Current FDA listing Historical FDA.report record 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 · 12 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…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 66 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 2026-02-19 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…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214542-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL RS 2021-06-02 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214542-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL RS 2021-06-02 6a51e52b5d6a…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 24338-403-12 24338040312 120 mL in 1 BOTTLE, PLASTIC (24338-403-12) 120 ml 2021-08-02 0000-00-00 No No Current