Home NDC 51079-487 Fluphenazine hydrochloride
Product NDC 51079-487
11-digit product format 510790487
Labeler code 51079
Product ID 51079-487_9c31c47b-4f7b-4800-e053-2a95a90ac060
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluphenazine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Institutional Inc.
Application ANDA089804
Marketing category ANDA
Marketing start 1998-06-04
Marketing end 2020-10-31
Substance FLUPHENAZINE HYDROCHLORIDE
Active strength 5 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 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 51079-487-20 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 51079-487-20 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 51079-487-20 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 51079-487-20 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 51079-487-20 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 51079-487-20 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 51079-487-20 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 51079-487-20 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 51079-487-20 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 51079-487-20 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 51079-487-20 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 51079-487-20 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 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 [MYLAN INSTITUTIONAL INC.] 3 FLUPHENAZINE ACTIVE MOIETY S79426A41Z FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 CALCIUM SULFATE INACTIVE INGREDIENT WAT0DDB505 FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 SODIUM ALGINATE INACTIVE INGREDIENT C269C4G2ZQ FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3