Home NDC 64380-900 FLUOXETINE HCL
Product NDC 64380-900
11-digit product format 643800900
Labeler code 64380
Product ID 64380-900_adcbffe8-9a0c-421a-9a18-21faac0207eb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluoxetine hcl
Dosage form TABLET
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA212683
Marketing category ANDA
Marketing start 2024-11-08
Substance FLUOXETINE
Active strength 60 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212683-001 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2024-09-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212683-001 AB
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 A212683-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2024-09-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212683-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2024-09-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212683-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2024-09-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212683-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2024-09-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212683-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2024-09-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212683-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2024-09-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212683-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2024-09-13 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212683-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2024-09-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212683-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2024-09-13 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212683-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2024-09-13 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base FLUOXETINE HCL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUOXETINE 60 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 01K63SUP8D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1190110 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 64380-900-04 FLUOXETINE HCL 30 in 1 BOTTLE TABLET 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-900 FLUOXETINE HCL TABLET [STRIDES PHARMA SCIENCE LIMITED] 3 Current NDC, 1 package rows 20241109_d09a5026-b3eb-403f-bf31-d5991a81a8ce.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 · 1 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 64380-900-04 64380090004 30 TABLET in 1 BOTTLE (64380-900-04) 30 tablet 2024-11-08 No No Current