Home NDC 62135-730 Fluoxetine
Product NDC 62135-730
11-digit product format 621350730
Labeler code 62135
Product ID 62135-730_4a16df46-6bfb-37c2-e063-6394a90a9525
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluoxetine
Dosage form LIQUID
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA076458
Marketing category ANDA
Marketing start 2004-05-14
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 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 A076458-001 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14
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 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076458-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2004-05-14 cb3db0bc1861…
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/5mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310386 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 62135-730-24 Fluoxetine 10 in 1 TRAY LIQUID 10 5 62135-730-24 Fluoxetine 2 in 1 BOX LIQUID 2 5 62135-730-41 Fluoxetine 120 mL in 1 BOTTLE LIQUID 120 5 62135-730-45 Fluoxetine 5 mL in 1 CUP LIQUID 5 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-730 FLUOXETINE LIQUID [CHARTWELL RX, LLC] 3 Current NDC, 4 package rows 20240526_cac17277-3481-4661-935f-efc48fff534c.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 62135-730-24 62135073024 2 TRAY in 1 BOX (62135-730-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-730-45) 2 tray 2024-05-23 No No Current 62135-730-41 62135073041 120 mL in 1 BOTTLE (62135-730-41) 120 ml 2023-09-27 No No Current 62135-730-45 62135073045 5 mL in 1 CUP 5 ml Historical