Escitalopram

Product NDC
68788-9302
11-digit product format
687889302
Labeler code
68788
Product ID
68788-9302_08386176-e94f-4a6f-be90-a41e70571506
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA076765
Marketing category
ANDA
Marketing start
2015-03-26
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
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-9302DDiscontinued by firm2026-08-17
excluded packagepackage68788-930268788-9302-1DDiscontinued by firm2026-08-17
excluded packagepackage68788-930268788-9302-2DDiscontinued by firm2026-08-17
excluded packagepackage68788-930268788-9302-3DDiscontinued by firm2026-08-17
excluded packagepackage68788-930268788-9302-6DDiscontinued by firm2026-08-17
excluded packagepackage68788-930268788-9302-9DDiscontinued by firm2026-08-17

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 · 72 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9302-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9302-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9302-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9302-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9302-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9302-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9302-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9302-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9302-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9302-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9302-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9302-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9302-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9302-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9302-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9302-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9302-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9302-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9302-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9302-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9302-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9302-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9302-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9302-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9302-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9302-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9302-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9302-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9302-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9302-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9302-6302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9302-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9302-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9302-9302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9302-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9302-6ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9302-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9302-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9302-9ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9302-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9302-60efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9302-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9302-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9302-90efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9302-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9302-6ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9302-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9302-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9302-9ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9302-3ad56d346431e…cc804d4bbf1e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076765-001ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORAL2012-03-14
A076765-002ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORAL2012-03-14
A076765-003ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORAL2012-03-14

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076765-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORAL2012-03-14caaa826d4ba7…
2026-08-18 06:07:402026-07A076765-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORAL2012-03-14caaa826d4ba7…
2026-08-18 06:07:402026-07A076765-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORAL2012-03-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076765-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORAL2012-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076765-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORAL2012-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076765-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORAL2012-03-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076765-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORAL2012-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076765-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORAL2012-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076765-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORAL2012-03-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A076765-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORAL2012-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076765-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORAL2012-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076765-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORAL2012-03-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076765-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORAL2012-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076765-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORAL2012-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076765-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORAL2012-03-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076765-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORAL2012-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076765-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORAL2012-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076765-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORAL2012-03-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076765-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORAL2012-03-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076765-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORAL2012-03-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076765-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORAL2012-03-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076765-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORAL2012-03-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076765-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORAL2012-03-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076765-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORAL2012-03-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076765-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORAL2012-03-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076765-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORAL2012-03-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076765-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORAL2012-03-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076765-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORAL2012-03-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076765-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORAL2012-03-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076765-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORAL2012-03-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076765-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORAL2012-03-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A076765-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORAL2012-03-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A076765-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORAL2012-03-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076765-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORAL2012-03-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076765-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORAL2012-03-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076765-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORAL2012-03-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076765-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORAL2012-03-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076765-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORAL2012-03-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076765-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORAL2012-03-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076765-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORAL2012-03-141e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 51 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076765-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076765-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076765-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076765-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076765-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076765-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076765-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076765-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076765-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076765-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076765-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076765-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076765-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076765-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076765-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076765-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A076765-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A076765-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076765-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076765-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076765-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076765-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A076765-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A076765-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076765-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A076765-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A076765-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076765-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A076765-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A076765-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076765-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076765-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076765-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076765-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076765-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076765-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076765-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076765-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076765-003AB1ea99ee380514…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076765-001AB13a93d1ddd44b…