Home NDC 63304-114 ChlorproMAZINE Hydrochloride
Product NDC 63304-114
11-digit product format 633040114
Labeler code 63304
Product ID 63304-114_c2d3824b-8e6f-414d-aa16-de9e2d448645
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ChlorproMAZINE
Dosage form TABLET, SUGAR COATED
Route ORAL
Labeler Sun Pharmaceutical Industries Inc
Application ANDA214256
Marketing category ANDA
Marketing start 2020-11-18
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 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 A214256-001 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2020-10-26 A214256-002 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL 2020-10-26 A214256-003 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL 2020-10-26 A214256-004 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL 2020-10-26 A214256-005 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL 2020-10-26
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 · 185 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 A214256-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2020-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214256-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL 2020-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214256-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL 2020-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214256-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL 2020-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214256-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL 2020-10-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214256-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2020-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214256-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL 2020-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214256-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL 2020-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214256-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL 2020-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214256-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL 2020-10-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214256-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2020-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214256-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL 2020-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214256-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL 2020-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214256-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL 2020-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214256-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL 2020-10-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214256-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2020-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214256-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL 2020-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214256-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL 2020-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214256-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL 2020-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214256-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL 2020-10-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214256-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214256-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2020-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214256-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2020-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214256-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214256-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-10-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214256-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214256-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2020-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214256-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2020-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214256-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214256-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-10-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214256-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-10-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214256-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2020-10-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214256-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2020-10-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214256-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-10-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214256-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-10-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214256-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-10-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214256-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2020-10-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214256-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2020-10-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214256-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-10-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214256-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-10-26 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 160 observed states.
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 63304-114-01 ChlorproMAZINE Hydrochloride 100 in 1 BOTTLE TABLET, SUGAR COATED 100 6 63304-114-10 ChlorproMAZINE Hydrochloride 1000 in 1 BOTTLE TABLET, SUGAR COATED 1000 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63304-114 CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE) TABLET, SUGAR COATED [SUN PHARMACEUTICAL INDUSTRIES INC] 6 Current NDC, Legacy NDC, 2 package rows 20220119_432cd4ca-c728-48ff-beec-2485f5e02512.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 Marketing start Marketing end Sample Exclude flag Status 63304-114-01 63304011401 100 TABLET, SUGAR COATED in 1 BOTTLE (63304-114-01) 2020-11-18 0000-00-00 No No Current 63304-114-10 63304011410 1000 TABLET, SUGAR COATED in 1 BOTTLE (63304-114-10) 2020-11-18 0000-00-00 No No Current