Home NDC 53808-0247 Fluphenazine Hydrochloride
Product NDC 53808-0247
11-digit product format 538080247
Labeler code 53808
Product ID 53808-0247_4589f1cd-5570-48bb-a94b-499faa06d4a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FLUPHENAZINE HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler State of Florida DOH Central Pharmacy
Application ANDA089804
Marketing category ANDA
Marketing start 2009-07-01
Marketing end 0000-00-00
Substance FLUPHENAZINE HYDROCHLORIDE
Active strength 5 mg/1
Pharmacologic classes Phenothiazines [CS],Phenothiazine [EPC]
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53808-0247-1 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53808-0247-1 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53808-0247-1 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53808-0247-1 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53808-0247-1 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53808-0247-1 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53808-0247-1 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53808-0247-1 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53808-0247-1 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53808-0247-1 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53808-0247-1 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 53808-0247-1 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product E Excluded after deficient or non-compliant submission was not corrected e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53808-0247-1 E Excluded after deficient or non-compliant submission was not corrected e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product E Excluded after deficient or non-compliant submission was not corrected 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53808-0247-1 E Excluded after deficient or non-compliant submission was not corrected 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53808-0247-1 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 A089804-001 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1988-08-12 A089804-002 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL 1988-08-12 A089804-003 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL 1988-08-12 A089804-004 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL 1988-08-12
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 · 172 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 A089804-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1988-08-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A089804-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL 1988-08-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A089804-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL 1988-08-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A089804-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL 1988-08-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A089804-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1988-08-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A089804-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL 1988-08-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A089804-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL 1988-08-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A089804-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL 1988-08-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A089804-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1988-08-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A089804-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL 1988-08-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A089804-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL 1988-08-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A089804-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL 1988-08-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089804-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1988-08-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089804-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL 1988-08-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089804-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL 1988-08-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089804-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL 1988-08-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089804-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1988-08-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A089804-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL 1988-08-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A089804-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL 1988-08-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A089804-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL 1988-08-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089804-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1988-08-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089804-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL 1988-08-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089804-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL 1988-08-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089804-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL 1988-08-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089804-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1988-08-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089804-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL 1988-08-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089804-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL 1988-08-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089804-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL 1988-08-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089804-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1988-08-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089804-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL 1988-08-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089804-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL 1988-08-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089804-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL 1988-08-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089804-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1988-08-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089804-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL 1988-08-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089804-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL 1988-08-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089804-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL 1988-08-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089804-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1988-08-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089804-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL 1988-08-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089804-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL 1988-08-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089804-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL 1988-08-12 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 FLUPHENAZINE ACTIVE MOIETY S79426A41Z FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 HYPROMELLOSE INACTIVE INGREDIENT 3NXW29V3WO FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 SODIUM ALGINATE INACTIVE INGREDIENT C269C4G2ZQ FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2