Home NDC 16714-050 Chlorpromazine hydrochloride
Product NDC 16714-050
11-digit product format 167140050
Labeler code 16714
Product ID 16714-050_a9a33076-fd77-4ae1-bff2-d4a4511a772a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Chlorpromazine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Northstar Rx LLC
Application ANDA213368
Marketing category ANDA
Marketing start 2020-05-11
Marketing end 2026-11-30
Substance CHLORPROMAZINE HYDROCHLORIDE
Active strength 100 mg/1
Pharmacologic classes Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag No
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 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 · 195 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 A213368-001 CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213368-002 CHLORPROMAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2020-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213368-003 CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2020-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213368-004 CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213368-005 CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET / ORAL AB 2020-01-17 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 195 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 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 16714-050-01 Chlorpromazine hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16714-050 CHLORPROMAZINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] 4 Current NDC, Legacy NDC, 1 package rows 20240814_2bd42d3a-bf89-4d74-a252-9b914106a570.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 Marketing start Marketing end Sample Exclude flag Status 16714-050-01 16714005001 100 TABLET, FILM COATED in 1 BOTTLE (16714-050-01) 2020-05-11 2026-11-30 No No Current