Home NDC 71610-534 Escitalopram oxalate
Product NDC 71610-534
11-digit product format 716100534
Labeler code 71610
Product ID 71610-534_2b8bb776-9f66-415a-b869-aded0e844450
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name escitalopram
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA078604
Marketing category ANDA
Marketing start 2012-10-01
Substance ESCITALOPRAM OXALATE
Active strength 20 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 A078604-001 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 A078604-002 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 A078604-003 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 A078604-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078604-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078604-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078604-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078604-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078604-003 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 A078604-001 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 A078604-002 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 A078604-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078604-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078604-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078604-003 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 A078604-001 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 A078604-002 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 A078604-003 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 A078604-001 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 A078604-002 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 A078604-003 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 A078604-001 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 A078604-002 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 A078604-003 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 A078604-001 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 A078604-002 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 A078604-003 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 A078604-001 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 A078604-002 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 A078604-003 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 A078604-001 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 A078604-002 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 A078604-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078604-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078604-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078604-003 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 A078604-001 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 A078604-002 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 A078604-003 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 A078604-001 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 A078604-002 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 A078604-003 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 A078604-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 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 20 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 71610-534-60 Escitalopram oxalate 90 in 1 BOTTLE TABLET, FILM COATED 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-534 ESCITALOPRAM OXALATE (ESCITALOPRAM ) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Current NDC, Legacy NDC, 1 package rows 20210424_900b7a2f-23e7-4c78-bd6e-549bbe09883e.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Escitalopram Oxalate ESCITALOPRAM REMEDYREPACK INC. 4508226c-5623-41d3-8916-5f94ffdb8839 2026-07-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078604 application number: ANDA078604 Escitalopram Oxalate ESCITALOPRAM Legacy Pharmaceutical Packaging, LLC 9c68f89b-1d34-4735-9631-817f012935d7 2026-03-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078604 application number: ANDA078604 Escitalopram Oxalate ESCITALOPRAM Cipla USA Inc. 31ce0b82-58fe-44f3-8887-c55d8df1b773 2025-10-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078604 application number: ANDA078604 Escitalopram oxalate ESCITALOPRAM Exelan Pharmaceuticals Inc. 8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd2 2024-07-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078604 application number: ANDA078604 Escitalopram oxalate ESCITALOPRAM Aphena Pharma Solutions - Tennessee, LLC 900b7a2f-23e7-4c78-bd6e-549bbe09883e 2021-04-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078604 application number: ANDA078604 ndc (product): 71610-534
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 71610-534-60 71610053460 90 TABLET, FILM COATED in 1 BOTTLE (71610-534-60) 2021-03-09 0000-00-00 No No Current