Home NDC 0832-1671-11 Fluvoxamine maleate
Product NDC 0832-1671
Requested package NDC 0832-1671-11
11-digit product format 008321671
Labeler code 0832
Product ID 0832-1671_45afd276-9f2a-23cd-e063-6294a90a0991
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluvoxamine maleate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Upsher-Smith Laboratories, LLC
Application ANDA075888
Marketing category ANDA
Marketing start 2000-11-29
Marketing end 2026-06-30
Substance FLUVOXAMINE MALEATE
Active strength 50 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075888-001 FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2000-11-29 A075888-002 FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2000-11-29 A075888-003 FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB RS 2000-11-29
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 · 123 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 A075888-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2000-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075888-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2000-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075888-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB RS 2000-11-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075888-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2000-11-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075888-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2000-11-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075888-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB RS 2000-11-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075888-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2000-11-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075888-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2000-11-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075888-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB RS 2000-11-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075888-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2000-11-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075888-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2000-11-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075888-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB RS 2000-11-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075888-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2000-11-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075888-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2000-11-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075888-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB RS 2000-11-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075888-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2000-11-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075888-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2000-11-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075888-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB RS 2000-11-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075888-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2000-11-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075888-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2000-11-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075888-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB RS 2000-11-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075888-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2000-11-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075888-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2000-11-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075888-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB RS 2000-11-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075888-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2000-11-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075888-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2000-11-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075888-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB RS 2000-11-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075888-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2000-11-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075888-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2000-11-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075888-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB RS 2000-11-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075888-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2000-11-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075888-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2000-11-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075888-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB RS 2000-11-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075888-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2000-11-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075888-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2000-11-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075888-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB RS 2000-11-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075888-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2000-11-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075888-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2000-11-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075888-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB RS 2000-11-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075888-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2000-11-29 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0832-1671-11 Fluvoxamine maleate 100 in 1 BOTTLE TABLET, FILM COATED 100 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0832-1671 FLUVOXAMINE MALEATE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, LLC] 9 Current NDC, Legacy NDC, 1 package rows 20231004_52b29024-b639-4c88-ac6c-0c64dbd204f4.zip
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 0832-1671-11 00832167111 100 TABLET, FILM COATED in 1 BOTTLE (0832-1671-11) 2020-01-08 0000-00-00 No No Current