Home NDC 70518-4273 Fluphenazine hydrochloride
Product NDC 70518-4273
11-digit product format 705184273
Labeler code 70518
Product ID 70518-4273_5025ebc2-a290-192f-e063-6294a90a0bce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluphenazine hydrochloride
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA217410
Marketing category ANDA
Marketing start 2025-02-03
Substance FLUPHENAZINE HYDROCHLORIDE
Active strength 5 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 A217410-001 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-01-05 A217410-002 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-01-05 A217410-003 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-01-05 A217410-004 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-01-05
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 3 · 104 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 A217410-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-01-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217410-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-01-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217410-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-01-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217410-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-01-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217410-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-01-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217410-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-01-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217410-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-01-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217410-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-01-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217410-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217410-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217410-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217410-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-01-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217410-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-01-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217410-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-01-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217410-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-01-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217410-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-01-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217410-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-01-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217410-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-01-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217410-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-01-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217410-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-01-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217410-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-01-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217410-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-01-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217410-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-01-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217410-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-01-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217410-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-01-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217410-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-01-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217410-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-01-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217410-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-01-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217410-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-01-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217410-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-01-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217410-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-01-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217410-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-01-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217410-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-01-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217410-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-01-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217410-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-01-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217410-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-01-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217410-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-01-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217410-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-01-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217410-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-01-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217410-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-01-05 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 100 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 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 860918 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 70518-4273-0 Fluphenazine hydrochloride 30 in 1 BLISTER PACK TABLET 30 4 70518-4273-1 Fluphenazine hydrochloride 50 in 1 BOX TABLET 50 4 70518-4273-2 Fluphenazine hydrochloride 1 in 1 POUCH TABLET 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-4273 FLUPHENAZINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] 2 Current NDC, 3 package rows 20250423_85720b55-3419-4e2c-95dd-22eec035d6f1.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 Sample Exclude flag Status 70518-4273-0 70518427300 30 TABLET in 1 BLISTER PACK (70518-4273-0) 30 tablet 2025-02-03 No No Current 70518-4273-1 70518427301 50 POUCH in 1 BOX (70518-4273-1) / 1 TABLET in 1 POUCH (70518-4273-2) 50 pouch 2026-04-23 No No Current 70518-4273-2 70518427302 1 in 1 POUCH Historical