Home NDC 10135-725 FLUPHENAZINE HYDROCHLORIDE
Product NDC 10135-725
11-digit product format 101350725
Labeler code 10135
Product ID 10135-725_437e142c-e2e3-2b97-e063-6294a90a9266
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FLUPHENAZINE HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler Marlex Pharmaceuticals, Inc.
Application ANDA214674
Marketing category ANDA
Marketing start 2021-06-01
Substance FLUPHENAZINE HYDROCHLORIDE
Active strength 1 mg/1
Pharmacologic classes Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A214674-001 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2021-03-01 A214674-002 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2021-03-01 A214674-003 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2021-03-01 A214674-004 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-03-01
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 · 144 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 2026-09-14 22:38:34 2026-08 A214674-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2021-03-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214674-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2021-03-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214674-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2021-03-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214674-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-03-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214674-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2021-03-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214674-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2021-03-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214674-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2021-03-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214674-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-03-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214674-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2021-03-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214674-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2021-03-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214674-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2021-03-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214674-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-03-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214674-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2021-03-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214674-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2021-03-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214674-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2021-03-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214674-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-03-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214674-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2021-03-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214674-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2021-03-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214674-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2021-03-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214674-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-03-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214674-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2021-03-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214674-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2021-03-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214674-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2021-03-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214674-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-03-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214674-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2021-03-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214674-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2021-03-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214674-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2021-03-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214674-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-03-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214674-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2021-03-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214674-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2021-03-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214674-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2021-03-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214674-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-03-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214674-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2021-03-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214674-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2021-03-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214674-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2021-03-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214674-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-03-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214674-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2021-03-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214674-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2021-03-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214674-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2021-03-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214674-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-03-01 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 144 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10135-725-01 FLUPHENAZINE HYDROCHLORIDE 100 in 1 BOTTLE TABLET 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10135-725 FLUPHENAZINE HYDROCHLORIDE TABLET [MARLEX PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20241009_c69f07b1-660c-db03-e053-2995a90a5464.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 10135-725-01 10135072501 100 TABLET in 1 BOTTLE (10135-725-01) 100 tablet 2021-06-01 0000-00-00 No No Current