Home NDC 68001-197 Escitalopram
Product NDC 68001-197
11-digit product format 680010197
Labeler code 68001
Product ID 68001-197_c4f837db-92b5-7684-e053-2a95a90acfe2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Escitalopram Oxalate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler BluePoint Laboratories
Application ANDA202280
Marketing category ANDA
Marketing start 2014-02-06
Marketing end 2024-01-31
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 0000-00-00
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A202280-001 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 A202280-002 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-12 A202280-003 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-12
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 A202280-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202280-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202280-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202280-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202280-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202280-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202280-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202280-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202280-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202280-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202280-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202280-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202280-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202280-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202280-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202280-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202280-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202280-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202280-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202280-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202280-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202280-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202280-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202280-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202280-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202280-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202280-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202280-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202280-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202280-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202280-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202280-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202280-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202280-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202280-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202280-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202280-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202280-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202280-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202280-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-12 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Escitalopram oxalate ACTIVE INGREDIENT 5U85DBW7LO ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 Escitalopram ACTIVE MOIETY 4O4S742ANY ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 Cellulose, Microcrystalline INACTIVE INGREDIENT OP1R32D61U ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 Hypromelloses INACTIVE INGREDIENT 3NXW29V3WO ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 Polyethylene Glycol 400 INACTIVE INGREDIENT B697894SGQ ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 Silicon Dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 Talc INACTIVE INGREDIENT 7SEV7J4R1U ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 Escitalopram oxalate ACTIVE INGREDIENT 5U85DBW7LO ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY] 1 Escitalopram ACTIVE MOIETY 4O4S742ANY ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY] 1 Cellulose, Microcrystalline INACTIVE INGREDIENT OP1R32D61U ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY] 1 Croscarmellose Sodium INACTIVE INGREDIENT M28OL1HH48 ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY] 1 Hypromelloses INACTIVE INGREDIENT 3NXW29V3WO ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY] 1 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY] 1 Polyethylene Glycol 400 INACTIVE INGREDIENT B697894SGQ ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY] 1 Silicon Dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY] 1 Talc INACTIVE INGREDIENT 7SEV7J4R1U ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY] 1 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY] 1
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Escitalopram ESCITALOPRAM OXALATE Jubilant Cadista Pharmaceuticals Inc. 2db02476-325f-ee47-a7e5-b5aed56c364c 2026-07-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202280 application number: ANDA202280
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68001-197-00 68001019700 100 TABLET, FILM COATED in 1 BOTTLE (68001-197-00) 2014-02-06 2024-01-31 No No Current 68001-197-03 68001019703 500 TABLET, FILM COATED in 1 BOTTLE (68001-197-03) 2014-02-06 2024-01-31 No No Current