Home NDC 60687-419 CHLORPROMAZINE HYDROCHLORIDE
Product NDC 60687-419
11-digit product format 606870419
Labeler code 60687
Product ID 60687-419_5c40c6d8-d1c5-3b27-e063-6394a90a07db
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CHLORPROMAZINE HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler American Health Packaging
Application ANDA209755
Marketing category ANDA
Marketing start 2019-06-13
Substance CHLORPROMAZINE HYDROCHLORIDE
Active strength 10 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 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 A209755-001 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-10 A209755-002 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2018-09-10 A209755-003 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2018-09-10 A209755-004 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-09-10 A209755-005 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2018-09-10
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 6 · 215 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 A209755-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209755-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2018-09-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209755-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2018-09-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209755-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-09-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209755-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2018-09-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209755-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209755-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2018-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209755-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2018-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209755-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209755-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2018-09-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209755-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209755-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2018-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209755-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2018-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209755-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209755-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2018-09-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209755-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209755-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2018-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209755-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2018-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209755-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209755-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2018-09-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209755-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209755-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2018-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209755-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2018-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209755-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209755-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2018-09-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209755-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209755-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2018-09-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209755-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2018-09-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209755-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-09-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209755-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2018-09-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209755-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209755-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2018-09-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209755-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2018-09-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209755-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-09-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209755-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2018-09-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209755-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209755-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2018-09-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209755-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2018-09-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209755-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-09-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209755-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2018-09-10 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 215 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORPROMAZINE HYDROCHLORIDE 10 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60687-419-01 CHLORPROMAZINE HYDROCHLORIDE 100 in 1 BOX, UNIT-DOSE TABLET, FILM COATED 100 5 60687-419-11 CHLORPROMAZINE HYDROCHLORIDE 1 in 1 BLISTER PACK TABLET, FILM COATED 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60687-419 CHLORPROMAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4 Current NDC, Legacy NDC, 2 package rows 20240525_d43718e5-66d7-44f9-9fc8-80d38d3e41ce.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 Units Marketing start Marketing end Sample Exclude flag Status 60687-419-01 60687041901 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-419-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-419-11) 100 blister pack 2019-06-13 0000-00-00 No No Current 60687-419-11 60687041911 1 in 1 BLISTER PACK Historical