Home NDC 51672-4233 Fluphenazine Hydrochloride
Product NDC 51672-4233
11-digit product format 516724233
Labeler code 51672
Product ID 51672-4233_4db5cdb5-b848-695f-e063-6294a90a25b5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluphenazine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA215674
Marketing category ANDA
Marketing start 2022-04-14
Substance FLUPHENAZINE HYDROCHLORIDE
Active strength 1 mg/1
Pharmacologic classes Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 8 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 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 51672-4233-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 51672-4233-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 51672-4233-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 51672-4233-1 1332a3947898…d4bfe170f9cd…
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 A215674-001 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2022-04-14 A215674-002 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2022-04-14 A215674-003 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-04-14 A215674-004 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-04-14
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 3 · 116 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 A215674-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2022-04-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215674-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2022-04-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215674-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-04-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215674-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-04-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215674-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2022-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215674-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2022-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215674-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215674-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-04-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215674-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2022-04-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215674-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2022-04-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215674-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-04-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215674-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-04-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215674-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2022-04-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215674-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2022-04-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215674-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-04-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215674-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-04-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215674-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2022-04-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215674-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2022-04-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215674-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-04-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215674-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-04-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215674-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2022-04-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215674-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2022-04-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215674-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-04-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215674-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-04-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215674-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2022-04-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215674-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2022-04-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215674-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-04-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215674-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-04-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215674-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2022-04-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215674-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2022-04-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215674-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-04-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215674-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-04-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215674-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2022-04-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215674-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2022-04-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215674-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-04-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215674-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-04-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215674-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2022-04-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215674-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2022-04-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215674-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-04-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215674-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-04-14 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 116 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Fluphenazine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUPHENAZINE HYDROCHLORIDE 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ZOU145W1XL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 859841 Internal RxNorm lookup 860918 Internal RxNorm lookup 865117 Internal RxNorm lookup 865123 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-4233-1 Fluphenazine Hydrochloride 1 in 1 CARTON TABLET, FILM COATED 1 5 51672-4233-1 Fluphenazine Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4233 FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A. INC.] 4 Current NDC, Legacy NDC, 2 package rows 20250303_7036f7c6-0792-400d-a1c7-54f21b2bd481.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-4233-1 51672423301 1 BOTTLE in 1 CARTON (51672-4233-1) / 100 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2022-04-14 0000-00-00 No No Current