Home NDC 0615-1501 Fluphenazine Hydrochloride
Product NDC 0615-1501
11-digit product format 006151501
Labeler code 0615
Product ID 0615-1501_6c9ae111-faaa-4660-8f3f-c012e1e2ff68
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluphenazine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NCS HealthCare of KY, Inc dba Vangard Labs
Application ANDA089804
Marketing category ANDA
Marketing start 1988-08-12
Marketing end 0000-00-00
Substance FLUPHENAZINE HYDROCHLORIDE
Active strength 5 mg/1
Pharmacologic classes Phenothiazines [CS],Phenothiazine [EPC]
NDC exclude flag No
Listing certified through 2019-12-31
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0615-1501-39 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0615-1501-39 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0615-1501-39 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0615-1501-39 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0615-1501-39 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0615-1501-39 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0615-1501-39 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0615-1501-39 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0615-1501-39 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0615-1501-39 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0615-1501-39 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0615-1501-39 557ba5c1ecfa…9c80585c8c6e…
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 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 · 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 A089804-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1988-08-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 A089804-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL 1988-08-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 A089804-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL 1988-08-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 A089804-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL 1988-08-12 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A089804-001 AB 1 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A089804-002 AB 1 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A089804-003 AB 1 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A089804-004 AB 1 cb3db0bc1861…
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 [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 FLUPHENAZINE ACTIVE MOIETY S79426A41Z FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 HYPROMELLOSE INACTIVE INGREDIENT 3NXW29V3WO FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 SODIUM ALGINATE INACTIVE INGREDIENT C269C4G2ZQ FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1