Home NDC 62135-423 chlorpromazine hydrochloride
Product NDC 62135-423
11-digit product format 621350423
Labeler code 62135
Product ID 62135-423_459bb2f6-3a40-6998-e063-6394a90a7e2f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name chlorpromazine hydrochloride
Dosage form TABLET, SUGAR COATED
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA212630
Marketing category ANDA
Marketing start 2022-02-05
Substance CHLORPROMAZINE HYDROCHLORIDE
Active strength 100 mg/1
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 43 .
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 A212630-001 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-11-29 A212630-002 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2021-11-29 A212630-003 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2021-11-29 A212630-004 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-11-29 A212630-005 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2021-11-29
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 · 175 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 2026-09-14 22:38:34 2026-08 A212630-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-11-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A212630-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2021-11-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A212630-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2021-11-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A212630-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-11-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A212630-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2021-11-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212630-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-11-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212630-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2021-11-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212630-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2021-11-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212630-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-11-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212630-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2021-11-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212630-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212630-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2021-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212630-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2021-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212630-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212630-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2021-11-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212630-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-11-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212630-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2021-11-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212630-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2021-11-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212630-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-11-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212630-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2021-11-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212630-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-11-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212630-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2021-11-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212630-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2021-11-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212630-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-11-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212630-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2021-11-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212630-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-11-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212630-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2021-11-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212630-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2021-11-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212630-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-11-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212630-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2021-11-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212630-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-11-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212630-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2021-11-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212630-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2021-11-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212630-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-11-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212630-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2021-11-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212630-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-11-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212630-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2021-11-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212630-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2021-11-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212630-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2021-11-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212630-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2021-11-29 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 175 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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/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 62135-423-90 chlorpromazine hydrochloride 90 in 1 BOTTLE TABLET, SUGAR COATED 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-423 CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [CHARTWELL RX, LLC] 3 Current NDC, Legacy NDC, 1 package rows 20241011_e9d6a9e9-ba25-4c25-9b03-25897a3ac5f3.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 62135-423-90 62135042390 90 TABLET, SUGAR COATED in 1 BOTTLE (62135-423-90) 2022-10-20 0000-00-00 No No Current