Home NDC 0904-7131-61 Chlorpromazine hydrochloride
Product NDC 0904-7131
Requested package NDC 0904-7131-61
11-digit product format 009047131
Labeler code 0904
Product ID 0904-7131_efc16dbf-a0d5-4693-a2e0-d114d265f07b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Chlorpromazine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA213368
Marketing category ANDA
Marketing start 2020-01-27
Marketing end 0000-00-00
Substance CHLORPROMAZINE HYDROCHLORIDE
Active strength 50 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A213368-001 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-01-17 A213368-002 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2020-01-17 A213368-003 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2020-01-17 A213368-004 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-01-17 A213368-005 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-01-17
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 · 190 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 A213368-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-01-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213368-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2020-01-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213368-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2020-01-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213368-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-01-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213368-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-01-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213368-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-01-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213368-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2020-01-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213368-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2020-01-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213368-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-01-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213368-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-01-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213368-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213368-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2020-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213368-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2020-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213368-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213368-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-01-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213368-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-01-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213368-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2020-01-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213368-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2020-01-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213368-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-01-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213368-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-01-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213368-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-01-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213368-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2020-01-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213368-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2020-01-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213368-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-01-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213368-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-01-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213368-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-01-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213368-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2020-01-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213368-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2020-01-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213368-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-01-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213368-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-01-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213368-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-01-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213368-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2020-01-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213368-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2020-01-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213368-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-01-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213368-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-01-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213368-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-01-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213368-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2020-01-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213368-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2020-01-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213368-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-01-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213368-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-01-17 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 190 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0904-7131-61 Chlorpromazine hydrochloride 1 in 1 BLISTER PACK TABLET, FILM COATED 1 7 0904-7131-61 Chlorpromazine hydrochloride 100 in 1 CARTON TABLET, FILM COATED 100 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7131 CHLORPROMAZINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 5 Legacy NDC, 2 package rows 20241018_d58570a0-58b0-4662-b2ad-aa8d1463b4c1.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0904-7131-61 00904713161 100 BLISTER PACK in 1 CARTON (0904-7131-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK 100 blister pack 2020-01-27 0000-00-00 No No Current