Home NDC 68180-998 Fluoxetine Hydrochloride
Product NDC 68180-998
11-digit product format 681800998
Labeler code 68180
Product ID 68180-998_71041a6b-43e4-415c-a1a6-dbd55a09a0d6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluoxetine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA211653
Marketing category ANDA
Marketing start 2019-08-07
Substance FLUOXETINE HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A211653-001 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-04-15 A211653-002 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-04-15
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.
Product history page 1 of 3 · 86 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 2026-09-14 22:38:34 2026-08 A211653-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-04-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211653-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-04-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211653-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-04-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211653-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-04-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211653-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211653-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-04-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211653-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211653-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-04-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211653-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211653-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-04-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211653-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-04-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211653-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-04-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211653-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-04-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211653-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-04-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211653-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-04-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211653-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-04-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211653-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-04-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211653-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-04-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211653-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-04-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211653-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-04-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211653-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-04-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211653-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-04-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211653-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-04-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211653-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-04-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211653-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-04-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211653-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-04-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211653-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-04-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211653-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-04-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211653-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-04-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211653-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-04-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211653-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-04-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211653-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-04-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211653-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-04-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211653-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-04-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211653-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-04-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211653-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-04-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211653-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-04-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211653-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-04-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211653-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-04-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A211653-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-04-15 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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 Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUOXETINE HYDROCHLORIDE 10 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 68180-998-01 Fluoxetine Hydrochloride 100 in 1 BOTTLE TABLET 100 10 68180-998-06 Fluoxetine Hydrochloride 30 in 1 BOTTLE TABLET 30 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-998 FLUOXETINE HYDROCHLORIDE TABLET [LUPIN PHARMACEUTICALS, INC.] 10 Current NDC, Legacy NDC, 2 package rows 20230810_dd659085-c32d-4d35-9d4b-bafa2a93f1fb.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 Marketing end Sample Exclude flag Status 68180-998-01 68180099801 100 TABLET in 1 BOTTLE (68180-998-01) 100 tablet 2019-08-07 0000-00-00 No No Current 68180-998-06 68180099806 30 TABLET in 1 BOTTLE (68180-998-06) 30 tablet 2019-08-07 0000-00-00 No No Current