Home NDC 42543-726 Fluoxetine
Product NDC 42543-726
11-digit product format 425430726
Labeler code 42543
Product ID 42543-726_f1764ef9-4324-4e97-a72c-d54bb09245ba
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluoxetine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Vensun Pharmaceuticals, Inc.
Application ANDA204597
Marketing category ANDA
Marketing start 2015-03-16
Substance FLUOXETINE HYDROCHLORIDE
Active strength 20 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 A204597-001 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 A204597-002 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2015-03-16 A204597-003 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2015-03-16
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 A204597-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 A204597-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2015-03-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 A204597-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2015-03-16 c2088c7a36db…2026-09-14 22:38:34 2026-08 A204597-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204597-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2015-03-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204597-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2015-03-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204597-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204597-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2015-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204597-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2015-03-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204597-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204597-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2015-03-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204597-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2015-03-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204597-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204597-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2015-03-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204597-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2015-03-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204597-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204597-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2015-03-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204597-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2015-03-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204597-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204597-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2015-03-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204597-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2015-03-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204597-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204597-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2015-03-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204597-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2015-03-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204597-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204597-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2015-03-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204597-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2015-03-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204597-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204597-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2015-03-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204597-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2015-03-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204597-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204597-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2015-03-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204597-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2015-03-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204597-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204597-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2015-03-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204597-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2015-03-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204597-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204597-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2015-03-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204597-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2015-03-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204597-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 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 Fluoxetine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUOXETINE HYDROCHLORIDE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination I9W7N6B1KJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310384 Internal RxNorm lookup 310385 Internal RxNorm lookup 313989 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 42543-726-01 Fluoxetine 100 in 1 BOTTLE CAPSULE 100 9 42543-726-05 Fluoxetine 500 in 1 BOTTLE CAPSULE 500 9 42543-726-10 Fluoxetine 1000 in 1 BOTTLE CAPSULE 1000 9 42543-726-30 Fluoxetine 30 in 1 BOTTLE CAPSULE 30 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUOXETINE HYDROCHLORIDE ACTIVE INGREDIENT I9W7N6B1KJ FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.] 1 FLUOXETINE ACTIVE MOIETY 01K63SUP8D FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.] 1 AMMONIA INACTIVE INGREDIENT 5138Q19F1X FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.] 1 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.] 1 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.] 1 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42543-726 FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [VENSUN PHARMACEUTICALS, INC.] 9 Current NDC, Legacy NDC, 4 package rows 20171031_b4f37ef1-8f5e-4318-90f1-2d8f8afb669c.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 3 of 3 · 42 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 42543-726-01 42543072601 100 CAPSULE in 1 BOTTLE (42543-726-01) 100 capsule 2015-03-16 0000-00-00 No No Current 42543-726-05 42543072605 500 CAPSULE in 1 BOTTLE (42543-726-05) 500 capsule 2015-03-16 0000-00-00 No No Current 42543-726-10 42543072610 1000 CAPSULE in 1 BOTTLE (42543-726-10) 1000 capsule 2015-03-16 0000-00-00 No No Current 42543-726-30 42543072630 30 CAPSULE in 1 BOTTLE (42543-726-30) 30 capsule 2015-03-16 0000-00-00 No No Current