Home NDC 59651-570 Chlorpromazine Hydrochloride
Product NDC 59651-570
11-digit product format 596510570
Labeler code 59651
Product ID 59651-570_22ddf306-4ee5-4358-900d-1e76b14bf237
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Chlorpromazine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA216788
Marketing category ANDA
Marketing start 2025-04-25
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 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 A216788-001 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2025-04-25 A216788-002 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2025-04-25 A216788-003 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2025-04-25 A216788-004 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2025-04-25 A216788-005 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2025-04-25
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.
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 A216788-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2025-04-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216788-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2025-04-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216788-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2025-04-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216788-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2025-04-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216788-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2025-04-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216788-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2025-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216788-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2025-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216788-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2025-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216788-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2025-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216788-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2025-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216788-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2025-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216788-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2025-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216788-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2025-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216788-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2025-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216788-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2025-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216788-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2025-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216788-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2025-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216788-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2025-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216788-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2025-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216788-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2025-04-25 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216788-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2025-04-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216788-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2025-04-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216788-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2025-04-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216788-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2025-04-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216788-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2025-04-25 a50c72e98297…
Observed Orange Book normalized TE history# 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59651-570-01 Chlorpromazine Hydrochloride 100 in 1 BOTTLE TABLET 100 3 59651-570-99 Chlorpromazine Hydrochloride 1000 in 1 BOTTLE TABLET 1000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-570 CHLORPROMAZINE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED] 1 Current NDC, 2 package rows 20250507_c2a8b8a3-187f-4000-bde3-b40bb0e5600f.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 59651-570-01 59651057001 100 TABLET in 1 BOTTLE (59651-570-01) 100 tablet 2025-04-25 No No Current 59651-570-99 59651057099 1000 TABLET in 1 BOTTLE (59651-570-99) 1000 tablet 2025-04-25 No No Current