Home NDC 0121-0852-40 Escitalopram Oxalate
Product NDC 0121-0852
Requested package NDC 0121-0852-40
11-digit product format 001210852
Labeler code 0121
Product ID 0121-0852_ed852c05-8604-dbed-e053-2995a90a5de0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Escitalopram Oxalate
Dosage form SOLUTION
Route ORAL
Labeler Pharmaceutical Associates, Inc.
Application ANDA090477
Marketing category ANDA
Marketing start 2013-05-30
Marketing end 0000-00-00
Substance ESCITALOPRAM OXALATE
Active strength 10 mg/10mL
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 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-04-09 23:13 UTC · source 2022-04-08 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 I Inactivated by FDA bd6a592717d7…303034d00443…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A090477-001 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090477-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
FDA-Initiated Inactive NDC Indexing# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0121-0852-40 00121085240 4 TRAY in 1 CASE (0121-0852-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (0121-0852-10) 4 tray 2018-06-04 0000-00-00 No No Current