Home NDC 70518-3435 Chlorpromazine Hydrochloride
Product NDC 70518-3435
11-digit product format 705183435
Labeler code 70518
Product ID 70518-3435_e451d28f-3363-6a8f-e053-2995a90ae56b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Chlorpromazine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA212144
Marketing category ANDA
Marketing start 2022-06-13
Marketing end 0000-00-00
Substance CHLORPROMAZINE HYDROCHLORIDE
Active strength 25 mg/1
Pharmacologic classes Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70518-3435-0 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70518-3435-0 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 70518-3435-0 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 70518-3435-0 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 70518-3435-0 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 70518-3435-0 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 70518-3435-0 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 70518-3435-0 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 70518-3435-0 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 70518-3435-0 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 70518-3435-0 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 70518-3435-0 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212144-001 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-03-23 A212144-002 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2021-03-23 A212144-003 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2021-03-23 A212144-004 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-03-23 A212144-005 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2021-03-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 5 · 170 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 A212144-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-03-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212144-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2021-03-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212144-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2021-03-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212144-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-03-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212144-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2021-03-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212144-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-03-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212144-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2021-03-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212144-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2021-03-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212144-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-03-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212144-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2021-03-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212144-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-03-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212144-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2021-03-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212144-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2021-03-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212144-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-03-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212144-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2021-03-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212144-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-03-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212144-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2021-03-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212144-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2021-03-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212144-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-03-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212144-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2021-03-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212144-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-03-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212144-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2021-03-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212144-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2021-03-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212144-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-03-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212144-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2021-03-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212144-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-03-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212144-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2021-03-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212144-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2021-03-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212144-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-03-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212144-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2021-03-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212144-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-03-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212144-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2021-03-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212144-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2021-03-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212144-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-03-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212144-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2021-03-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212144-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-03-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212144-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2021-03-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212144-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2021-03-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212144-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-03-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212144-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2021-03-23 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 170 observed states.
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 Marketing start Marketing end Sample Exclude flag Status 70518-3435-0 70518343500 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3435-0) 2022-06-13 0000-00-00 No No Current