Home NDC 72205-112-91 Fluphenazine Hydrochloride
Product NDC 72205-112
Requested package NDC 72205-112-91
11-digit product format 722050112
Labeler code 72205
Product ID 72205-112_f99e9ea5-3c4a-4a94-9ca9-709f65b8fd82
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluphenazine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Novadoz Pharmaceuticals LLC
Application ANDA217189
Marketing category ANDA
Marketing start 2023-09-11
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 A217189-001 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-09-11 A217189-002 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-09-11 A217189-003 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-09-11 A217189-004 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-09-11
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 · 88 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 A217189-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217189-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217189-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217189-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-09-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217189-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217189-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217189-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217189-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-09-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217189-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217189-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217189-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217189-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-09-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217189-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217189-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217189-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217189-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-09-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217189-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217189-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217189-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217189-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-09-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217189-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217189-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217189-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217189-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-09-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217189-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-09-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217189-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-09-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217189-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-09-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217189-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-09-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217189-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-09-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217189-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-09-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217189-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-09-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217189-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-09-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217189-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-09-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217189-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-09-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217189-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-09-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217189-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-09-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217189-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-09-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217189-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-09-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217189-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-09-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217189-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-09-11 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 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 72205-112-05 Fluphenazine Hydrochloride 500 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 500 2 72205-112-91 Fluphenazine Hydrochloride 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72205-112 FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC] 2 Current NDC, 2 package rows 20250322_83ce71b9-28eb-4074-b1e7-192ed254c529.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 Marketing start Sample Exclude flag Status 72205-112-91 72205011291 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72205-112-91) 2023-09-14 No No Current