Home NDC 33342-036 Escitalopram Oxalate
Product NDC 33342-036
11-digit product format 333420036
Labeler code 33342
Product ID 33342-036_53210109-53db-4d08-8ea4-be60e5597caf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Escitalopram Oxalate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA202210
Marketing category ANDA
Marketing start 2012-09-11
Substance ESCITALOPRAM OXALATE
Active strength 5 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 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202210-001 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 A202210-002 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 A202210-003 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 126 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 A202210-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202210-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202210-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202210-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202210-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202210-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202210-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202210-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202210-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202210-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202210-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202210-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202210-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202210-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202210-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202210-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202210-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202210-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202210-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202210-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202210-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202210-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202210-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202210-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202210-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202210-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202210-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202210-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202210-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202210-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202210-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202210-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202210-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202210-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202210-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202210-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202210-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202210-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202210-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202210-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 69 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Escitalopram Oxalate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESCITALOPRAM OXALATE 5 mg/1
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349332 Internal RxNorm lookup 351249 Internal RxNorm lookup 351250 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 33342-036-11 Escitalopram Oxalate 100 in 1 BOTTLE TABLET, FILM COATED 100 21 33342-036-12 Escitalopram Oxalate 100 in 1 CARTON TABLET, FILM COATED 100 21 33342-036-15 Escitalopram Oxalate 500 in 1 BOTTLE TABLET, FILM COATED 500 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ESCITALOPRAM OXALATE ACTIVE INGREDIENT 5U85DBW7LO ESCITALOPRAM OXALATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 ESCITALOPRAM ACTIVE MOIETY 4O4S742ANY ESCITALOPRAM OXALATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 ESCITALOPRAM OXALATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ESCITALOPRAM OXALATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 ESCITALOPRAM OXALATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 ESCITALOPRAM OXALATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ESCITALOPRAM OXALATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ESCITALOPRAM OXALATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ESCITALOPRAM OXALATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 PROPYL GALLATE INACTIVE INGREDIENT 8D4SNN7V92 ESCITALOPRAM OXALATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ESCITALOPRAM OXALATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 TALC INACTIVE INGREDIENT 7SEV7J4R1U ESCITALOPRAM OXALATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ESCITALOPRAM OXALATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-036 ESCITALOPRAM OXALATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 21 Current NDC, Legacy NDC, 3 package rows 20240525_24b43cb4-1a26-44a2-b1d8-a40239eb5c7c.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Escitalopram Oxalate ESCITALOPRAM OXALATE A-S Medication Solutions 76993020-6715-4090-847e-0fdcc5328f31 2024-07-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202210 application number: ANDA202210 Escitalopram Oxalate ESCITALOPRAM OXALATE A-S Medication Solutions c980262b-31f0-46df-902d-e593e1557fef 2024-07-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202210 application number: ANDA202210 Escitalopram Oxalate ESCITALOPRAM OXALATE NorthStar RxLLC 81840aec-96fd-4af2-bd10-3f38d068f39a 2024-07-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202210 application number: ANDA202210 Escitalopram Oxalate ESCITALOPRAM OXALATE Macleods Pharmaceuticals Limited 24b43cb4-1a26-44a2-b1d8-a40239eb5c7c 2024-05-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202210 application number: ANDA202210 ndc (product): 33342-036
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 33342-036-11 33342003611 100 TABLET, FILM COATED in 1 BOTTLE (33342-036-11) 2012-09-11 No No Current 33342-036-12 33342003612 100 TABLET, FILM COATED in 1 CARTON (33342-036-12) 2012-09-11 No No Current 33342-036-15 33342003615 500 TABLET, FILM COATED in 1 BOTTLE (33342-036-15) 2015-09-09 No No Current