Home NDC 60687-244 Fluoxetine
Product NDC 60687-244
11-digit product format 606870244
Labeler code 60687
Product ID 60687-244_eb90443d-cb1d-b3a4-e053-2995a90a29e1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluoxetine Hydrochloride
Dosage form LIQUID
Route ORAL
Labeler American Health Packaging
Application ANDA077849
Marketing category ANDA
Marketing start 2018-06-01
Marketing end 0000-00-00
Substance FLUOXETINE HYDROCHLORIDE
Active strength 20 mg/5mL
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 32 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A077849-001 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077849-001 AA
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 2 · 41 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 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077849-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2007-02-09 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fluoxetine FLUOXETINE HYDROCHLORIDE Lannett Company, Inc. c856d72f-4a1a-4f75-ae54-c4ac83ddcfa1 2023-08-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077849 application number: ANDA077849
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60687-244-67 60687024467 5 TRAY in 1 CASE (60687-244-67) > 10 CUP, UNIT-DOSE in 1 TRAY (60687-244-46) > 5 mL in 1 CUP, UNIT-DOSE (60687-244-40) 5 tray 2018-06-01 0000-00-00 No No Current 60687-244-77 60687024477 4 TRAY in 1 CASE (60687-244-77) > 10 CUP, UNIT-DOSE in 1 TRAY (60687-244-46) > 5 mL in 1 CUP, UNIT-DOSE (60687-244-40) 4 tray 2019-01-15 0000-00-00 No No Current