Home NDC 59115-101 Escitalopram
Product NDC 59115-101
11-digit product format 591150101
Labeler code 59115
Product ID 59115-101_f69a6fca-cfaf-48d8-86c9-a5ef6bd660ea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Escitalopram
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Hikma Pharmaceutical
Application ANDA078766
Marketing category ANDA
Marketing start 2012-09-11
Marketing end 0000-00-00
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 2020-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A078766-001 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-09-11 A078766-002 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-09-11 A078766-003 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-09-11
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 · 123 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 2026-02-19 14:30 UTC 2026-02 A078766-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078766-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078766-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-09-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078766-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078766-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078766-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-09-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078766-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078766-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078766-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-09-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078766-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078766-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078766-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-09-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078766-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-09-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078766-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-09-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078766-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-09-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078766-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-09-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078766-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-09-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078766-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-09-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078766-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-09-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078766-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-09-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078766-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-09-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078766-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-09-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078766-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-09-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078766-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-09-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078766-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-09-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078766-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-09-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078766-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-09-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078766-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-09-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078766-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-09-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078766-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-09-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078766-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-09-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078766-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-09-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078766-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-09-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078766-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-09-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078766-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-09-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078766-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-09-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078766-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-09-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078766-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-09-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078766-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-09-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078766-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-09-11 8072bd15b7f6…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ESCITALOPRAM OXALATE ACTIVE INGREDIENT 5U85DBW7LO ESCITALOPRAM TABLET, FILM COATED [HIKMA PHARMACEUTICAL] 2 ESCITALOPRAM ACTIVE MOIETY 4O4S742ANY ESCITALOPRAM TABLET, FILM COATED [HIKMA PHARMACEUTICAL] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ESCITALOPRAM TABLET, FILM COATED [HIKMA PHARMACEUTICAL] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ESCITALOPRAM TABLET, FILM COATED [HIKMA PHARMACEUTICAL] 2 HYPROMELLOSE 2208 (100 MPA.S) INACTIVE INGREDIENT B1QE5P712K ESCITALOPRAM TABLET, FILM COATED [HIKMA PHARMACEUTICAL] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ESCITALOPRAM TABLET, FILM COATED [HIKMA PHARMACEUTICAL] 2 POLYETHYLENE GLYCOL 300 INACTIVE INGREDIENT 5655G9Y8AQ ESCITALOPRAM TABLET, FILM COATED [HIKMA PHARMACEUTICAL] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ESCITALOPRAM TABLET, FILM COATED [HIKMA PHARMACEUTICAL] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U ESCITALOPRAM TABLET, FILM COATED [HIKMA PHARMACEUTICAL] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ESCITALOPRAM TABLET, FILM COATED [HIKMA PHARMACEUTICAL] 2