Home NDC 71205-838-11 Fluphenazine Hydrochloride
Product NDC 71205-838
Requested package NDC 71205-838-11
11-digit product format 712050838
Labeler code 71205
Product ID 71205-838_bc22941e-d2e7-4165-91ea-7239c8b9882d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluphenazine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application ANDA215848
Marketing category ANDA
Marketing start 2022-08-01
Substance FLUPHENAZINE HYDROCHLORIDE
Active strength 2.5 mg/1
Pharmacologic classes Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 A215848-001 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL 2022-04-01 A215848-002 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL 2022-04-01 A215848-003 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2022-04-01 A215848-004 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL 2022-12-14
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 · 122 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 A215848-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL 2022-04-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215848-002 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL 2022-04-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215848-003 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2022-04-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215848-004 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL 2022-12-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215848-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL 2022-04-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215848-002 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL 2022-04-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215848-003 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2022-04-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215848-004 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL 2022-12-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215848-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL 2022-04-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215848-002 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL 2022-04-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215848-003 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2022-04-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215848-004 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL 2022-12-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215848-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL 2022-04-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215848-002 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL 2022-04-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215848-003 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2022-04-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215848-004 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL 2022-12-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215848-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL 2022-04-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215848-002 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL 2022-04-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215848-003 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2022-04-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215848-004 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL 2022-12-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215848-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2022-04-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215848-002 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-04-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215848-003 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-04-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215848-004 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2022-12-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215848-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2022-04-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215848-002 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-04-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215848-003 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-04-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215848-004 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2022-12-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215848-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2022-04-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215848-002 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-04-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215848-003 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-04-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215848-004 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2022-12-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215848-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2022-04-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215848-002 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-04-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215848-003 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-04-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215848-004 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2022-12-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215848-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2022-04-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215848-002 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-04-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215848-003 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-04-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215848-004 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2022-12-14 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 98 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUPHENAZINE HYDROCHLORIDE 2.5 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 71205-838-00 Fluphenazine Hydrochloride 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 1 71205-838-11 Fluphenazine Hydrochloride 1000 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 1000 1 71205-838-30 Fluphenazine Hydrochloride 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 1 71205-838-55 Fluphenazine Hydrochloride 500 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 500 1 71205-838-60 Fluphenazine Hydrochloride 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 1 71205-838-64 Fluphenazine Hydrochloride 240 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 240 1 71205-838-72 Fluphenazine Hydrochloride 120 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 120 1 71205-838-78 Fluphenazine Hydrochloride 180 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 180 1 71205-838-90 Fluphenazine Hydrochloride 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-838 FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] 1 Current NDC, 9 package rows 20230225_bc22941e-d2e7-4165-91ea-7239c8b9882d.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 Marketing start Sample Exclude flag Status 71205-838-11 71205083811 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-838-11) 2023-02-21 No No Current