Home NDC 0527-1789 Fluphenazine Hydrochloride
Product NDC 0527-1789
11-digit product format 005271789
Labeler code 0527
Product ID 0527-1789_59cf1ea7-b827-4780-bf94-cd3446d6dcc3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluphenazine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA089743
Marketing category ANDA
Marketing start 1988-08-25
Substance FLUPHENAZINE HYDROCHLORIDE
Active strength 2.5 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 44 .
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 A089743-001 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1988-08-25 A089743-002 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 1988-08-25 A089743-003 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 1988-08-25 A089743-004 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1988-08-25
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 5 · 176 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 2026-10-15 13:18:30 2026-09 A089743-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1988-08-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 A089743-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 1988-08-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 A089743-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 1988-08-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 A089743-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1988-08-25 c2088c7a36db…2026-09-14 22:38:34 2026-08 A089743-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1988-08-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A089743-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 1988-08-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A089743-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 1988-08-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A089743-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1988-08-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A089743-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1988-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A089743-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 1988-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A089743-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 1988-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A089743-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1988-08-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A089743-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1988-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A089743-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 1988-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A089743-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 1988-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A089743-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1988-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089743-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1988-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089743-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 1988-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089743-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 1988-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089743-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1988-08-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089743-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1988-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A089743-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 1988-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A089743-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 1988-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A089743-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1988-08-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089743-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1988-08-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089743-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 1988-08-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089743-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 1988-08-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089743-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1988-08-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089743-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1988-08-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089743-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 1988-08-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089743-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 1988-08-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089743-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1988-08-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089743-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1988-08-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089743-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 1988-08-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089743-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 1988-08-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089743-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1988-08-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089743-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1988-08-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089743-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 1988-08-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089743-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 1988-08-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089743-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1988-08-25 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 5 · 176 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 2.5 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 0527-1789-01 Fluphenazine Hydrochloride 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 18 0527-1789-05 Fluphenazine Hydrochloride 500 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 500 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUPHENAZINE HYDROCHLORIDE ACTIVE INGREDIENT ZOU145W1XL FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 7 FLUPHENAZINE ACTIVE MOIETY S79426A41Z FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 7 D&C RED NO. 27 INACTIVE INGREDIENT 2LRS185U6K FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 7 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 7 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 7 DIBASIC CALCIUM PHOSPHATE DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 7 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 7 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 7 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 7 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 7 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 7 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 7 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 7 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 7 WATER INACTIVE INGREDIENT 059QF0KO0R FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0527-1789 FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 18 Current NDC, Legacy NDC, 2 package rows 20241121_6cd6ba35-3481-48c1-87db-dc74ce9d7d75.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 0527-1789-01 00527178901 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1789-01) 1988-08-25 0000-00-00 No No Current 0527-1789-05 00527178905 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1789-05) 1988-08-25 0000-00-00 No No Current