Home NDC 0781-1436 Fluphenazine Hydrochloride
Product NDC 0781-1436
11-digit product format 007811436
Labeler code 0781
Product ID 0781-1436_f404131c-0b3b-4615-a708-d28d56f9af81
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluphenazine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sandoz Inc
Application ANDA089586
Marketing category ANDA
Marketing start 1987-10-16
Marketing end 2019-10-31
Substance FLUPHENAZINE HYDROCHLORIDE
Active strength 1 mg/1
Pharmacologic classes Phenothiazines [CS],Phenothiazine [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
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 2 · 72 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A089586-001 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1987-10-16 A089586-002 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL 1987-10-16 A089586-003 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL 1987-10-16 A089586-004 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL 1987-10-16
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 A089586-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1987-10-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 A089586-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL 1987-10-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 A089586-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL 1987-10-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 A089586-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL 1987-10-16 c2088c7a36db…2026-09-14 22:38:34 2026-08 A089586-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1987-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A089586-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL 1987-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A089586-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL 1987-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A089586-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL 1987-10-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A089586-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1987-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A089586-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL 1987-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A089586-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL 1987-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A089586-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL 1987-10-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A089586-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1987-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A089586-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL 1987-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A089586-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL 1987-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A089586-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL 1987-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089586-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1987-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089586-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL 1987-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089586-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL 1987-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089586-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL 1987-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089586-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1987-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A089586-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL 1987-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A089586-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL 1987-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A089586-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL 1987-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089586-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1987-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089586-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL 1987-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089586-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL 1987-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089586-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL 1987-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089586-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1987-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089586-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL 1987-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089586-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL 1987-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089586-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL 1987-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089586-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1987-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089586-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL 1987-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089586-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL 1987-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089586-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL 1987-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089586-001 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1987-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089586-002 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL 1987-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089586-003 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL 1987-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089586-004 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL 1987-10-16 2680178bc6a6…
Observed Orange Book normalized TE history# 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 [SANDOZ INC] 14 FLUPHENAZINE ACTIVE MOIETY S79426A41Z FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 14 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 14 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 14 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 14 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 14 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 14 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 14 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 14 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 14 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 14 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 14 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 14 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 14 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 14 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 14 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 14