Home NDC 63323-281 Fluphenazine Hydrochloride
Product NDC 63323-281
11-digit product format 633230281
Labeler code 63323
Product ID 63323-281_cefdb059-d32b-44f2-8dd6-fd2a29b3ba70
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FLUPHENAZINE HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR
Labeler Fresenius Kabi USA, LLC
Application ANDA089556
Marketing category ANDA
Marketing start 2010-12-28
Substance FLUPHENAZINE HYDROCHLORIDE
Active strength 2.5 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 A089556-001 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16
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 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A089556-001 FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION RS 1987-04-16 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 2.5 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 865129 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 63323-281-10 Fluphenazine Hydrochloride 10 mL in 1 VIAL INJECTION, SOLUTION 10 4 63323-281-10 Fluphenazine Hydrochloride 1 in 1 BOX INJECTION, SOLUTION 1 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUPHENAZINE HYDROCHLORIDE ACTIVE INGREDIENT ZOU145W1XL FLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION [TYA PHARMACEUTICALS] 2 FLUPHENAZINE ACTIVE MOIETY S79426A41Z FLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION [TYA PHARMACEUTICALS] 2 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB FLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION [TYA PHARMACEUTICALS] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T FLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION [TYA PHARMACEUTICALS] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH FLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION [TYA PHARMACEUTICALS] 2 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X FLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION [TYA PHARMACEUTICALS] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I FLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION [TYA PHARMACEUTICALS] 2 FLUPHENAZINE HYDROCHLORIDE ACTIVE INGREDIENT ZOU145W1XL FLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 FLUPHENAZINE ACTIVE MOIETY S79426A41Z FLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB FLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T FLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH FLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X FLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I FLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-281 FLUPHENAZINE HYDROCHLORIDE (FLUPHENAZINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20241019_d571f04f-6190-42f2-932c-5a075fd978b9.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 63323-281-10 63323028110 1 VIAL in 1 BOX (63323-281-10) / 10 mL in 1 VIAL 1 vial 2010-12-28 0000-00-00 No No Current