Home NDC 33342-053 escitalopram
Product NDC 33342-053
11-digit product format 333420053
Labeler code 33342
Product ID 33342-053_6dea1a7d-7262-4d3e-9c9e-1db9c8587066
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name escitalopram
Dosage form SOLUTION
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA202754
Marketing category ANDA
Marketing start 2016-03-31
Substance ESCITALOPRAM OXALATE
Active strength 5 mg/5mL
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 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 A202754-001 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202754-001 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 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202754-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2016-03-31 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base escitalopram
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESCITALOPRAM OXALATE 5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5U85DBW7LO Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 351285 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 33342-053-28 escitalopram 240 mL in 1 BOTTLE SOLUTION 240 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-053 ESCITALOPRAM SOLUTION [MACLEODS PHARMACEUTICALS LIMITED] 11 Current NDC, Legacy NDC, 1 package rows 20240525_4d5c3142-b850-49b9-9f5c-81fe15ea7bfb.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 33342-053-28 33342005328 240 mL in 1 BOTTLE (33342-053-28) 240 ml 2016-03-31 0000-00-00 No No Current