Home NDC 42023-129 Fluphenazine Decanoate
Product NDC 42023-129
11-digit product format 420230129
Labeler code 42023
Product ID 42023-129_2b4eaada-361c-40fb-8c74-de1f30f2d9e3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluphenazine Decanoate
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; SUBCUTANEOUS
Labeler Par Health USA, LLC
Application ANDA203732
Marketing category ANDA
Marketing start 2018-06-26
Substance FLUPHENAZINE DECANOATE
Active strength 25 mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203732-001 FLUPHENAZINE DECANOATE FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203732-001 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 · 43 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 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203732-001 FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE / INJECTION AO 2014-07-03 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 Decanoate
Listing expiration 2027-12-31 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 42023-129-01 Fluphenazine Decanoate 1 in 1 CARTON INJECTION, SOLUTION 1 13 42023-129-01 Fluphenazine Decanoate 5 mL in 1 VIAL INJECTION, SOLUTION 5 13 42023-129-89 Fluphenazine Decanoate 5 mL in 1 VIAL INJECTION, SOLUTION 5 6 42023-129-89 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 [PAR PHARMACEUTICAL, INC.] 3 Fluphenazine ACTIVE MOIETY S79426A41Z FLUPHENAZINE DECANOATE INJECTION, SOLUTION [PAR PHARMACEUTICAL, INC.] 3 Benzyl Alcohol INACTIVE INGREDIENT LKG8494WBH FLUPHENAZINE DECANOATE INJECTION, SOLUTION [PAR PHARMACEUTICAL, INC.] 3 sesame oil INACTIVE INGREDIENT QX10HYY4QV FLUPHENAZINE DECANOATE INJECTION, SOLUTION [PAR PHARMACEUTICAL, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42023-129 FLUPHENAZINE DECANOATE INJECTION, SOLUTION [ENDO USA, INC.] 13 Current NDC, Legacy NDC, 2 package rows 20250131_b580471f-44a1-4da0-96ad-2f537eabec3e.zip 42023-129 FLUPHENAZINE DECANOATE INJECTION, SOLUTION [ENDO USA, INC.] 6 Current NDC, Legacy NDC, 2 package rows 20250205_970e6fde-9cc8-475b-8a9e-bde0579a72a7.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 Units Marketing start Marketing end Sample Exclude flag Status 42023-129-01 42023012901 1 VIAL in 1 CARTON (42023-129-01) / 5 mL in 1 VIAL 1 vial 2014-07-09 0000-00-00 No No Current 42023-129-89 42023012989 1 VIAL in 1 CARTON (42023-129-89) / 5 mL in 1 VIAL 1 vial 2018-06-26 0000-00-00 No No Current