Home NDC 60505-0164-1 Fluvoxamine Maleate
Product NDC 60505-0164
Requested package NDC 60505-0164-1
11-digit product format 605050164
Labeler code 60505
Product ID 60505-0164_2aa18614-fba5-8c56-f4fd-e8cb590e2284
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluvoxamine Maleate
Dosage form TABLET
Route ORAL
Labeler Apotex Corp
Application ANDA075902
Marketing category ANDA
Marketing start 2001-07-10
Substance FLUVOXAMINE MALEATE
Active strength 25 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
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 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075902-001 FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 A075902-002 FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2001-05-07 A075902-003 FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2001-05-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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.
Product history page 1 of 4 · 132 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 2026-10-15 13:18:30 2026-09 A075902-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 A075902-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2001-05-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 A075902-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2001-05-07 c2088c7a36db…2026-09-14 22:38:34 2026-08 A075902-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075902-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2001-05-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075902-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2001-05-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075902-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075902-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2001-05-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075902-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2001-05-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075902-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075902-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2001-05-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075902-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2001-05-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075902-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075902-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2001-05-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075902-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2001-05-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075902-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075902-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2001-05-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075902-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2001-05-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075902-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075902-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2001-05-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075902-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2001-05-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075902-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075902-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2001-05-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075902-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2001-05-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075902-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075902-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2001-05-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075902-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2001-05-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075902-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075902-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2001-05-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075902-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2001-05-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075902-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075902-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2001-05-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075902-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2001-05-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075902-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075902-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2001-05-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075902-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2001-05-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075902-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075902-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2001-05-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075902-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2001-05-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075902-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 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 Fluvoxamine Maleate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUVOXAMINE MALEATE 25 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-0164-1 Fluvoxamine Maleate 100 in 1 BOTTLE TABLET 100 15 60505-0164-2 Fluvoxamine Maleate 1000 in 1 BOTTLE TABLET 1000 15
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-0164 FLUVOXAMINE MALEATE TABLET [APOTEX CORP] 14 Current NDC, Legacy NDC, 2 package rows 20240214_6eeb14df-6fcf-a737-5359-5744eb4accea.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fluvoxamine Maleate FLUVOXAMINE MALEATE American Health Packaging 0b107225-ed5a-4461-9184-f3f2bad1892f 2026-06-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075902 application number: ANDA075902 Fluvoxamine Maleate FLUVOXAMINE MALEATE Preferred Pharmaceuticals Inc. a4e0212a-ce68-4466-a0e4-f87d5d9ff0b3 2026-04-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075902 application number: ANDA075902 Fluvoxamine Maleate FLUVOXAMINE MALEATE Bryant Ranch Prepack 4239fc32-e5cb-4393-b90c-742db42b5d07 2026-01-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075902 application number: ANDA075902 Fluvoxamine Maleate FLUVOXAMINE MALEATE Bryant Ranch Prepack 47daea9e-545d-4a67-b2b2-d12c3c98734b 2026-01-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075902 application number: ANDA075902
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 60505-0164-1 60505016401 100 TABLET in 1 BOTTLE (60505-0164-1) 100 tablet 2001-07-10 0000-00-00 No No Current