Home NDC 16714-674-01 Fluphenazine Hydrochloride
Product NDC 16714-674
Requested package NDC 16714-674-01
11-digit product format 167140674
Labeler code 16714
Product ID 16714-674_941b9852-e201-488d-b959-382312335b21
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluphenazine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Northstar Rx LLC
Application ANDA214552
Marketing category ANDA
Marketing start 2021-11-24
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 2022-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A214552-001 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2021-05-27 A214552-002 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2021-05-27 A214552-003 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2021-05-27 A214552-004 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-05-27
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 4 · 132 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 2026-02-19 14:30 UTC 2026-02 A214552-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2021-05-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214552-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2021-05-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214552-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2021-05-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214552-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-05-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214552-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2021-05-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214552-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2021-05-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214552-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2021-05-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214552-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-05-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214552-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2021-05-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214552-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2021-05-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214552-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2021-05-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214552-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-05-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214552-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2021-05-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214552-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2021-05-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214552-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2021-05-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214552-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-05-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214552-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2021-05-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214552-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2021-05-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214552-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2021-05-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214552-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-05-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214552-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2021-05-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214552-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2021-05-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214552-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2021-05-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214552-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-05-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214552-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2021-05-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214552-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2021-05-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214552-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2021-05-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214552-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-05-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214552-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2021-05-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214552-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2021-05-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214552-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2021-05-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214552-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-05-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214552-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2021-05-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214552-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2021-05-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214552-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2021-05-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214552-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-05-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214552-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2021-05-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214552-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2021-05-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214552-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2021-05-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214552-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-05-27 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16714-674 FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] 4 Legacy NDC 20241207_6a87fecd-f339-430b-8943-02117ad70211.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 16714-674-01 16714067401 100 TABLET, FILM COATED in 1 BOTTLE (16714-674-01) 2021-11-24 0000-00-00 No No Current