Home NDC 59651-688-60 Fluphenazine Hydrochloride
Product NDC 59651-688
Requested package NDC 59651-688-60
11-digit product format 596510688
Labeler code 59651
Product ID 59651-688_1109b107-f7af-45b7-b8ee-709c59123074
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluphenazine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA218055
Marketing category ANDA
Marketing start 2023-08-18
Substance FLUPHENAZINE HYDROCHLORIDE
Active strength 5 mg/1
Pharmacologic classes Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 14 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 21:27 UTC · source 2025-12-05 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 50b4072663b7…eae3003ed65e…
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 A218055-001 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-08-18 A218055-002 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-08-18 A218055-003 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-08-18 A218055-004 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-18
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 2 · 80 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 A218055-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-08-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218055-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-08-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218055-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-08-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218055-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218055-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-08-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218055-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-08-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218055-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-08-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218055-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218055-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-08-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218055-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-08-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218055-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-08-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218055-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218055-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-08-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218055-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-08-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218055-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-08-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218055-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218055-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-08-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218055-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-08-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218055-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-08-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218055-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218055-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-08-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218055-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-08-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218055-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-08-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218055-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218055-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-08-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218055-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-08-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218055-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-08-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218055-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218055-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-08-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218055-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-08-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218055-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-08-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218055-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218055-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-08-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218055-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-08-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218055-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-08-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218055-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218055-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-08-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A218055-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-08-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A218055-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-08-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A218055-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-18 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Fluphenazine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUPHENAZINE HYDROCHLORIDE 5 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59651-688-01 Fluphenazine Hydrochloride 100 in 1 BOTTLE TABLET 100 3 59651-688-05 Fluphenazine Hydrochloride 500 in 1 BOTTLE TABLET 500 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-688 FLUPHENAZINE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED] 3 Current NDC, 2 package rows 20241121_e73764e7-e666-4ad3-a029-04a528dc1c9e.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Status 59651-688-60 59651068860 60000 TABLET in 1 BAG (59651-688-60) 60000 tablet 18-AUG-23 Current