Home NDC 69238-1678 fluphenazine hydrochloride
Product NDC 69238-1678
11-digit product format 692381678
Labeler code 69238
Product ID 69238-1678_e350dbeb-6212-43b1-8c85-f60fb1719e0f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluphenazine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA213647
Marketing category ANDA
Marketing start 2020-07-11
Substance FLUPHENAZINE HYDROCHLORIDE
Active strength 1 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213647-001 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2020-07-09 A213647-002 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2020-07-09 A213647-003 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-09 A213647-004 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-09
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 4 · 156 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 A213647-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2020-07-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213647-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2020-07-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213647-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213647-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213647-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2020-07-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213647-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2020-07-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213647-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213647-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213647-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2020-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213647-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2020-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213647-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213647-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213647-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2020-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213647-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2020-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213647-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213647-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213647-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2020-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213647-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2020-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213647-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213647-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213647-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2020-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213647-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2020-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213647-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213647-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213647-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2020-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213647-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2020-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213647-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213647-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213647-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2020-07-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213647-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2020-07-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213647-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213647-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213647-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2020-07-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213647-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2020-07-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213647-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213647-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213647-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2020-07-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213647-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2020-07-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213647-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213647-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-09 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 156 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUPHENAZINE HYDROCHLORIDE 1 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 69238-1678-1 fluphenazine hydrochloride 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-1678 FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC] 10 Current NDC, Legacy NDC, 1 package rows 20231231_5b443b30-5682-4cf3-9ed0-716efddbc865.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 Marketing start Marketing end Sample Exclude flag Status 69238-1678-1 69238167801 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69238-1678-1) 2020-07-11 0000-00-00 No No Current