Home NDC 64380-903 FLUOXETINE
Product NDC 64380-903
11-digit product format 643800903
Labeler code 64380
Product ID 64380-903_35d9874e-1471-484c-b625-29e70a190e10
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluoxetine
Dosage form TABLET
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA212684
Marketing category ANDA
Marketing start 2024-08-12
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 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212684-001 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2024-04-05 A212684-002 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2024-04-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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.
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 A212684-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2024-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212684-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2024-04-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212684-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2024-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212684-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2024-04-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212684-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2024-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212684-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2024-04-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212684-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2024-04-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212684-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2024-04-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212684-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2024-04-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212684-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2024-04-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212684-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2024-04-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212684-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2024-04-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212684-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2024-04-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212684-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2024-04-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212684-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2024-04-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212684-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2024-04-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212684-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2024-04-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212684-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2024-04-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212684-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2024-04-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212684-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2024-04-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212684-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2024-04-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212684-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2024-04-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212684-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2024-04-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212684-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2024-04-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212684-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2024-04-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212684-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2024-04-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212684-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2024-04-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212684-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2024-04-05 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212684-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2024-04-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212684-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2024-04-05 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 248642 Internal RxNorm lookup 313990 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 64380-903-04 FLUOXETINE 30 in 1 BOTTLE TABLET 30 6 64380-903-06 FLUOXETINE 100 in 1 BOTTLE TABLET 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-903 FLUOXETINE TABLET [STRIDES PHARMA SCIENCE LIMITED] 5 Current NDC, 2 package rows 20240812_ca749349-d0e1-4b7c-b4c0-e392e72cf0f6.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 Sample Exclude flag Status 64380-903-04 64380090304 30 TABLET in 1 BOTTLE (64380-903-04) 30 tablet 2024-08-12 No No Current 64380-903-06 64380090306 100 TABLET in 1 BOTTLE (64380-903-06) 100 tablet 2024-08-12 No No Current