Home NDC 59746-280 Escitalopram
Product NDC 59746-280
11-digit product format 597460280
Labeler code 59746
Product ID 59746-280_1ba045ea-2f59-4bf4-94b3-d03449c0bf77
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Escitalopram Oxalate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Jubilant Cadista Pharmacuticals Inc.
Application ANDA202280
Marketing category ANDA
Marketing start 2023-12-01
Substance ESCITALOPRAM OXALATE
Active strength 10 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 A202280-001 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 A202280-002 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-12 A202280-003 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-12
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 A202280-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202280-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202280-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202280-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202280-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202280-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202280-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202280-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202280-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202280-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202280-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202280-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202280-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202280-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202280-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202280-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202280-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202280-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202280-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202280-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202280-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202280-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202280-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202280-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202280-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202280-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202280-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202280-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202280-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202280-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202280-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202280-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202280-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202280-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202280-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202280-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202280-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202280-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202280-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202280-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Escitalopram
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESCITALOPRAM OXALATE 10 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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 59746-280-01 2023-11-28 These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002 59746-280-01 2023-11-28 These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002 59746-280-05 2023-11-28 These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002 59746-280-05 2023-11-28 These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002 59746-280-10 2023-11-28 These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002 59746-280-10 2023-11-28 These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002 59746-280-30 2023-11-28 These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002 59746-280-30 2023-11-28 These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002 59746-280-90 2023-11-28 These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002 59746-280-90 2023-11-28 These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002 59746-280-01 2023-01-30 These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002 59746-280-01 2023-01-30 These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002 59746-280-05 2023-01-30 These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002 59746-280-05 2023-01-30 These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002 59746-280-10 2023-01-30 These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002 59746-280-10 2023-01-30 These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002 59746-280-30 2023-01-30 These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002 59746-280-30 2023-01-30 These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002 59746-280-90 2023-01-30 These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002 59746-280-90 2023-01-30 These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59746-280-01 Escitalopram 100 in 1 BOTTLE TABLET, FILM COATED 100 14 59746-280-05 Escitalopram 500 in 1 BOTTLE TABLET, FILM COATED 500 14 59746-280-10 Escitalopram 1000 in 1 BOTTLE TABLET, FILM COATED 1000 14 59746-280-30 Escitalopram 30 in 1 BOTTLE TABLET, FILM COATED 30 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Escitalopram oxalate ACTIVE INGREDIENT 5U85DBW7LO ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 8 Escitalopram ACTIVE MOIETY 4O4S742ANY ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 8 Cellulose, Microcrystalline INACTIVE INGREDIENT OP1R32D61U ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 8 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 8 Hypromelloses INACTIVE INGREDIENT 3NXW29V3WO ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 8 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 8 Polyethylene Glycol 400 INACTIVE INGREDIENT B697894SGQ ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 8 Silicon Dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 8 Talc INACTIVE INGREDIENT 7SEV7J4R1U ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 8 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59746-280 ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 13 Current NDC, Legacy NDC, 4 package rows 20240206_2db02476-325f-ee47-a7e5-b5aed56c364c.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Escitalopram ESCITALOPRAM OXALATE Jubilant Cadista Pharmaceuticals Inc. 2db02476-325f-ee47-a7e5-b5aed56c364c 2026-07-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202280 application number: ANDA202280 ndc (product): 59746-280
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 59746-280-01 59746028001 100 TABLET, FILM COATED in 1 BOTTLE (59746-280-01) 2024-01-01 0000-00-00 No No Current 59746-280-05 59746028005 500 TABLET, FILM COATED in 1 BOTTLE (59746-280-05) 2024-01-01 0000-00-00 No No Current 59746-280-10 59746028010 1000 TABLET, FILM COATED in 1 BOTTLE (59746-280-10) 2024-01-01 0000-00-00 No No Current 59746-280-30 59746028030 30 TABLET, FILM COATED in 1 BOTTLE (59746-280-30) 2024-01-01 0000-00-00 No No Current 59746-280-90 59746028090 90 TABLET, FILM COATED in 1 BOTTLE (59746-280-90) 2012-09-12 0000-00-00 No No Current