Home NDC 63187-281 Escitalopram
Product NDC 63187-281
11-digit product format 631870281
Labeler code 63187
Product ID 63187-281_4b1e6e75-c6ed-4a2c-be35-2a4deaea7def
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Escitalopram
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application ANDA076765
Marketing category ANDA
Marketing start 2012-03-14
Marketing end 0000-00-00
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 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63187-281-60 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63187-281-90 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63187-281-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63187-281-60 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63187-281-90 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63187-281-30 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A076765-001 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 A076765-002 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-03-14 A076765-003 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-03-14
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 · 132 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 2026-10-15 13:18:30 2026-09 A076765-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076765-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-03-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076765-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-03-14 c2088c7a36db…2026-09-14 22:38:34 2026-08 A076765-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076765-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076765-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-03-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076765-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076765-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076765-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-03-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076765-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076765-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076765-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-03-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076765-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076765-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076765-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-03-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076765-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076765-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076765-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-03-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076765-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076765-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076765-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-03-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076765-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076765-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076765-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-03-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076765-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076765-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-03-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076765-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-03-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076765-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076765-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-03-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076765-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-03-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076765-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076765-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-03-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076765-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-03-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076765-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076765-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-03-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076765-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-03-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076765-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076765-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-03-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076765-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-03-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076765-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 51 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ESCITALOPRAM OXALATE ACTIVE INGREDIENT 5U85DBW7LO ESCITALOPRAM TABLET, FILM COATED [PROFICIENT RX LP] 4 ESCITALOPRAM ACTIVE MOIETY 4O4S742ANY ESCITALOPRAM TABLET, FILM COATED [PROFICIENT RX LP] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ESCITALOPRAM TABLET, FILM COATED [PROFICIENT RX LP] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ESCITALOPRAM TABLET, FILM COATED [PROFICIENT RX LP] 4 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W ESCITALOPRAM TABLET, FILM COATED [PROFICIENT RX LP] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ESCITALOPRAM TABLET, FILM COATED [PROFICIENT RX LP] 4 MANNITOL INACTIVE INGREDIENT 3OWL53L36A ESCITALOPRAM TABLET, FILM COATED [PROFICIENT RX LP] 4 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE ESCITALOPRAM TABLET, FILM COATED [PROFICIENT RX LP] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ESCITALOPRAM TABLET, FILM COATED [PROFICIENT RX LP] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ESCITALOPRAM TABLET, FILM COATED [PROFICIENT RX LP] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-281 ESCITALOPRAM TABLET, FILM COATED [PROFICIENT RX LP] 7 Legacy NDC 20191121_eecd1c8c-9e8f-4618-8d71-b1d8116bd6d7.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63187-281-30 63187028130 30 TABLET, FILM COATED in 1 BOTTLE (63187-281-30) 2014-11-07 0000-00-00 No No Current 63187-281-60 63187028160 60 TABLET, FILM COATED in 1 BOTTLE (63187-281-60) 2014-11-07 0000-00-00 No No Current 63187-281-90 63187028190 90 TABLET, FILM COATED in 1 BOTTLE (63187-281-90) 2014-11-07 0000-00-00 No No Current