Home NDC 53746-019 Escitalopram Oxalate
Product NDC 53746-019
11-digit product format 537460019
Labeler code 53746
Product ID 53746-019_fe4fad91-a1c2-41f2-933d-94bdfb86d38c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Escitalopram Oxalate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA205619
Marketing category ANDA
Marketing start 2017-05-17
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 A205619-001 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2017-05-17 A205619-002 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2017-05-17 A205619-003 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2017-05-17
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 A205619-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2017-05-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205619-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2017-05-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205619-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2017-05-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205619-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2017-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205619-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2017-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205619-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2017-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205619-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2017-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205619-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2017-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205619-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2017-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205619-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2017-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205619-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2017-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205619-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2017-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205619-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2017-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205619-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2017-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205619-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2017-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205619-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2017-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205619-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2017-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205619-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2017-05-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205619-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2017-05-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205619-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2017-05-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205619-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2017-05-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205619-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2017-05-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205619-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2017-05-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205619-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2017-05-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205619-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2017-05-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205619-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2017-05-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205619-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2017-05-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205619-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2017-05-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205619-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2017-05-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205619-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2017-05-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205619-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2017-05-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205619-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2017-05-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205619-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2017-05-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205619-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2017-05-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205619-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2017-05-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205619-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2017-05-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205619-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2017-05-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205619-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2017-05-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205619-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2017-05-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205619-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2017-05-17 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 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 53746-019-05 Escitalopram Oxalate 500 in 1 BOTTLE TABLET, FILM COATED 500 3 53746-019-10 Escitalopram Oxalate 1000 in 1 BOTTLE TABLET, FILM COATED 1000 3 53746-019-30 Escitalopram Oxalate 30 in 1 BOTTLE TABLET, FILM COATED 30 3 53746-019-90 Escitalopram Oxalate 90 in 1 BOTTLE TABLET, FILM COATED 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53746-019 ESCITALOPRAM OXALATE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 3 Current NDC, 4 package rows 20241127_4f941d7a-5abb-4907-a7a1-480245deef87.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 Marketing start Sample Exclude flag Status 53746-019-05 53746001905 500 TABLET, FILM COATED in 1 BOTTLE (53746-019-05) 2017-05-17 No No Current 53746-019-10 53746001910 1000 TABLET, FILM COATED in 1 BOTTLE (53746-019-10) 2017-05-17 No No Current 53746-019-30 53746001930 30 TABLET, FILM COATED in 1 BOTTLE (53746-019-30) 2017-05-17 No No Current 53746-019-90 53746001990 90 TABLET, FILM COATED in 1 BOTTLE (53746-019-90) 2017-05-17 No No Current