Home NDC 63323-272 Fluphenazine Decanoate
Product NDC 63323-272
11-digit product format 633230272
Labeler code 63323
Product ID 63323-272_a7b2e2cb-f87a-46e7-8230-ec6b585f45cd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FLUPHENAZINE DECANOATE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; SUBCUTANEOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA071413
Marketing category ANDA
Marketing start 2010-12-15
Substance FLUPHENAZINE DECANOATE
Active strength 25 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 A071413-001 FLUPHENAZINE DECANOATE FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A071413-001 AO
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 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A071413-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO RS 1987-07-14 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Fluphenazine Decanoate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUPHENAZINE DECANOATE 25 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination FMU62K1L3C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 859824 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 63323-272-05 Fluphenazine Decanoate 5 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 5 6 63323-272-05 Fluphenazine Decanoate 1 in 1 CARTON INJECTION, SOLUTION 1 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUPHENAZINE DECANOATE ACTIVE INGREDIENT FMU62K1L3C FLUPHENAZINE DECANOATE INJECTION, SOLUTION [TYA PHARMACEUTICALS] 2 FLUPHENAZINE ACTIVE MOIETY S79426A41Z FLUPHENAZINE DECANOATE INJECTION, SOLUTION [TYA PHARMACEUTICALS] 2 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH FLUPHENAZINE DECANOATE INJECTION, SOLUTION [TYA PHARMACEUTICALS] 2 SESAME OIL INACTIVE INGREDIENT QX10HYY4QV FLUPHENAZINE DECANOATE INJECTION, SOLUTION [TYA PHARMACEUTICALS] 2 FLUPHENAZINE DECANOATE ACTIVE INGREDIENT FMU62K1L3C FLUPHENAZINE DECANOATE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 FLUPHENAZINE DECANOATE ACTIVE MOIETY FMU62K1L3C FLUPHENAZINE DECANOATE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH FLUPHENAZINE DECANOATE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 SESAME OIL INACTIVE INGREDIENT QX10HYY4QV FLUPHENAZINE DECANOATE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-272 FLUPHENAZINE DECANOATE (FLUPHENAZINE DECANOATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20241019_f8ba014e-aea0-49bc-8345-4e0a384b484e.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 Marketing end Sample Exclude flag Status 63323-272-05 63323027205 1 VIAL, MULTI-DOSE in 1 CARTON (63323-272-05) / 5 mL in 1 VIAL, MULTI-DOSE 2010-12-15 0000-00-00 No No Current