Home NDC 62332-790 Fluphenazine Hydrochloride
Product NDC 62332-790
11-digit product format 623320790
Labeler code 62332
Product ID 62332-790_f7ef2923-6d2a-4b1f-ad9c-c8127391b9f4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluphenazine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Alembic Pharmaceuticals Inc.
Application ANDA218173
Marketing category ANDA
Marketing start 2024-07-25
Substance FLUPHENAZINE HYDROCHLORIDE
Active strength 5 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218173-001 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2024-07-23 A218173-002 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2024-07-23 A218173-003 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2024-07-23 A218173-004 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2024-07-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 2 · 56 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 A218173-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2024-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218173-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2024-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218173-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2024-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218173-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2024-07-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218173-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2024-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218173-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2024-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218173-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2024-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218173-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2024-07-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218173-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2024-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218173-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2024-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218173-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2024-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218173-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2024-07-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218173-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2024-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218173-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2024-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218173-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2024-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218173-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2024-07-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218173-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2024-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218173-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2024-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218173-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2024-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218173-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2024-07-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218173-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2024-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218173-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2024-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218173-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2024-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218173-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2024-07-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218173-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2024-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218173-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2024-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218173-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2024-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218173-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2024-07-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218173-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2024-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218173-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2024-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218173-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2024-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218173-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2024-07-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218173-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2024-07-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218173-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2024-07-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218173-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2024-07-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218173-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2024-07-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218173-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2024-07-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218173-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2024-07-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218173-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2024-07-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218173-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2024-07-23 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 56 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 Fluphenazine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUPHENAZINE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ZOU145W1XL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 859841 Internal RxNorm lookup 860918 Internal RxNorm lookup 865117 Internal RxNorm lookup 865123 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 62332-790-31 Fluphenazine Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 5 62332-790-71 Fluphenazine Hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62332-790 FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.] 5 Current NDC, 2 package rows 20250112_1991be2c-9629-4c3e-93f0-e40bcffc82b0.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fluphenazine Hydrochloride FLUPHENAZINE HYDROCHLORIDE Coupler LLC 37c9712b-95a1-fcc4-e063-6394a90aca50 2025-06-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 218173 application number: ANDA218173 Fluphenazine Hydrochloride FLUPHENAZINE HYDROCHLORIDE Coupler LLC 325c8c34-2858-af36-e063-6394a90a7814 2025-04-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 218173 application number: ANDA218173 Fluphenazine Hydrochloride FLUPHENAZINE HYDROCHLORIDE Alembic Pharmaceuticals Inc. 1991be2c-9629-4c3e-93f0-e40bcffc82b0 2024-11-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 218173 application number: ANDA218173 ndc (product): 62332-790 Fluphenazine Hydrochloride FLUPHENAZINE HYDROCHLORIDE Alembic Pharmaceuticals Limited 7c29fb1f-9403-4e55-abd9-36adfb152e8e 2024-07-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 218173 application number: ANDA218173
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 62332-790-31 62332079031 100 TABLET, FILM COATED in 1 BOTTLE (62332-790-31) 2024-07-25 No No Current 62332-790-71 62332079071 500 TABLET, FILM COATED in 1 BOTTLE (62332-790-71) 2024-07-25 No No Current