Home NDC 31722-384-01 Fluphenazine Hydrochloride
Product NDC 31722-384
Requested package NDC 31722-384-01
11-digit product format 317220384
Labeler code 31722
Product ID 31722-384_4468c081-e6a4-bbbf-e063-6294a90aa886
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluphenazine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA218769
Marketing category ANDA
Marketing start 2025-11-18
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 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 A218769-001 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2025-11-18 A218769-002 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2025-11-18 A218769-003 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2025-11-18 A218769-004 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2025-11-18
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.
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 A218769-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2025-11-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218769-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2025-11-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218769-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2025-11-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218769-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2025-11-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218769-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2025-11-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218769-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2025-11-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218769-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2025-11-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218769-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2025-11-18 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218769-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2025-11-18 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218769-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2025-11-18 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218769-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2025-11-18 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218769-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2025-11-18 a50c72e98297…
Observed Orange Book normalized TE history# 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 31722-384-01 Fluphenazine Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 1 31722-384-05 Fluphenazine Hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 1
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 31722-384-01 31722038401 100 TABLET, FILM COATED in 1 BOTTLE (31722-384-01) 2025-11-18 No No Current