Home NDC 72888-457 chlorpromazine hydrochloride
Product NDC 72888-457
11-digit product format 728880457
Labeler code 72888
Product ID 72888-457_4144a379-1c55-ade1-e063-6394a90a66ff
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name chlorpromazine hydrochloride
Dosage form CONCENTRATE
Route ORAL
Labeler Advagen Pharma Ltd
Application ANDA216678
Marketing category ANDA
Marketing start 2025-10-10
Substance CHLORPROMAZINE HYDROCHLORIDE
Active strength 30 mg/mL
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216678-001 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL AA 2025-10-10 A216678-002 CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL AA 2025-10-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2026-09-14 22:38:34 2026-08 A216678-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL AA 2025-10-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216678-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL AA 2025-10-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216678-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL AA 2025-10-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216678-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL AA 2025-10-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216678-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL AB 2025-10-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216678-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL AB 2025-10-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216678-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL AB 2025-10-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216678-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL AB 2025-10-10 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216678-001 CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE / ORAL AA 2025-10-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216678-002 CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE / ORAL AA 2025-10-10 a50c72e98297…
Observed Orange Book normalized TE history# 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 30 mg/mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 991053 Internal RxNorm lookup 991332 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 72888-457-01 chlorpromazine hydrochloride 120 mL in 1 BOTTLE CONCENTRATE 120 3
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 72888-457-01 72888045701 120 mL in 1 BOTTLE (72888-457-01) 120 ml 2025-10-10 No No Current