Home NDC 63629-4699 Escitalopram
Product NDC 63629-4699
11-digit product format 636294699
Labeler code 63629
Product ID 63629-4699_edd9fe1d-ef9c-4eac-8d4b-4903f3447a38
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Escitalopram
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
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 2019-12-31
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 2 · 120 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 129 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 2026-09-14 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…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076765-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-03-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076765-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-03-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076765-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 51 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 63629-4699-1 2022-02-16 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 63629-4699-2 2022-02-16 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 63629-4699-3 2022-02-16 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 63629-4699-4 2022-02-16 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 63629-4699-5 2022-02-16 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 63629-4699-6 2022-02-16 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 63629-4699-7 2022-02-16 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 63629-4699-1 2020-01-31 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 63629-4699-2 2020-01-31 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 63629-4699-3 2020-01-31 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 63629-4699-4 2020-01-31 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 63629-4699-5 2020-01-31 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 63629-4699-6 2020-01-31 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 63629-4699-7 2020-01-31 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ESCITALOPRAM OXALATE ACTIVE INGREDIENT 5U85DBW7LO ESCITALOPRAM TABLET, FILM COATED [BRYANT RANCH PREPACK] 1002 ESCITALOPRAM ACTIVE MOIETY 4O4S742ANY ESCITALOPRAM TABLET, FILM COATED [BRYANT RANCH PREPACK] 1002 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ESCITALOPRAM TABLET, FILM COATED [BRYANT RANCH PREPACK] 1002 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ESCITALOPRAM TABLET, FILM COATED [BRYANT RANCH PREPACK] 1002 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W ESCITALOPRAM TABLET, FILM COATED [BRYANT RANCH PREPACK] 1002 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ESCITALOPRAM TABLET, FILM COATED [BRYANT RANCH PREPACK] 1002 MANNITOL INACTIVE INGREDIENT 3OWL53L36A ESCITALOPRAM TABLET, FILM COATED [BRYANT RANCH PREPACK] 1002 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE ESCITALOPRAM TABLET, FILM COATED [BRYANT RANCH PREPACK] 1002 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ESCITALOPRAM TABLET, FILM COATED [BRYANT RANCH PREPACK] 1002 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ESCITALOPRAM TABLET, FILM COATED [BRYANT RANCH PREPACK] 1002