Home NDC 0121-0653 Fluphenazine Hydrochloride
Product NDC 0121-0653
11-digit product format 001210653
Labeler code 0121
Product ID 0121-0653_4bf945f4-e607-409c-80f5-90195005d6a7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluphenazine Hydrochloride
Dosage form SOLUTION, CONCENTRATE
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
Application ANDA074725
Marketing category ANDA
Marketing start 2010-09-01
Substance FLUPHENAZINE HYDROCHLORIDE
Active strength 5 mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074725-001 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16
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 · 41 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 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074725-001 FLUPHENAZINE HYDROCHLORIDE 5MG/ML CONCENTRATE / ORAL RS 1996-09-16 cb3db0bc1861…
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/mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861848 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 0121-0653-04 Fluphenazine Hydrochloride 120 mL in 1 BOTTLE, DROPPER SOLUTION, CONCENTRATE 120 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Fluphenazine Hydrochloride ACTIVE INGREDIENT ZOU145W1XL FLUPHENAZINE HYDROCHLORIDE SOLUTION, CONCENTRATE [PHARMACEUTICAL ASSOCIATES, INC.] 3 Fluphenazine ACTIVE MOIETY S79426A41Z FLUPHENAZINE HYDROCHLORIDE SOLUTION, CONCENTRATE [PHARMACEUTICAL ASSOCIATES, INC.] 3 alcohol INACTIVE INGREDIENT 3K9958V90M FLUPHENAZINE HYDROCHLORIDE SOLUTION, CONCENTRATE [PHARMACEUTICAL ASSOCIATES, INC.] 3 Glycerin INACTIVE INGREDIENT PDC6A3C0OX FLUPHENAZINE HYDROCHLORIDE SOLUTION, CONCENTRATE [PHARMACEUTICAL ASSOCIATES, INC.] 3 Sodium Benzoate INACTIVE INGREDIENT OJ245FE5EU FLUPHENAZINE HYDROCHLORIDE SOLUTION, CONCENTRATE [PHARMACEUTICAL ASSOCIATES, INC.] 3 Water INACTIVE INGREDIENT 059QF0KO0R FLUPHENAZINE HYDROCHLORIDE SOLUTION, CONCENTRATE [PHARMACEUTICAL ASSOCIATES, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-0653 FLUPHENAZINE HYDROCHLORIDE SOLUTION, CONCENTRATE [PAI HOLDINGS, LLC DBA PAI PHARMA] 8 Current NDC, Legacy NDC, 1 package rows 20250210_0860b3f3-3116-40f8-bcb0-e5c47731bdc8.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 Marketing end Sample Exclude flag Status 0121-0653-04 00121065304 120 mL in 1 BOTTLE, DROPPER (0121-0653-04) 120 ml 2010-09-01 0000-00-00 No No Current