escitalopram oxalate

Product NDC
68788-6978
11-digit product format
687886978
Labeler code
68788
Product ID
68788-6978_ad946983-2613-4afc-937e-34a7290b429b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram oxalate
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA090939
Marketing category
ANDA
Marketing start
2017-06-06
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
2022-12-31
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 productproduct68788-6978DDiscontinued by firm2026-08-03
excluded packagepackage68788-697868788-6978-1DDiscontinued by firm2026-08-03
excluded packagepackage68788-697868788-6978-3DDiscontinued by firm2026-08-03
excluded packagepackage68788-697868788-6978-6DDiscontinued by firm2026-08-03
excluded packagepackage68788-697868788-6978-8DDiscontinued by firm2026-08-03
excluded packagepackage68788-697868788-6978-9DDiscontinued by firm2026-08-03

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 packagepackage68788-6978-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-6978-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-6978-8d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-6978-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-6978-6d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-6978-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-6978-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-6978-8f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-6978-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-6978-6f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-6978-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-6978-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-6978-82ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-6978-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-6978-62ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-6978-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-6978-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-6978-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-6978-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-6978-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-6978-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-6978-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-6978-8cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-6978-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-6978-6cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-6978-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-6978-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-6978-8cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-6978-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-6978-6cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-6978-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-6978-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-6978-8302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-6978-9302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-6978-6302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-6978-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-6978-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-6978-8ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-6978-9ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-6978-6ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-6978-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-6978-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-6978-80efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-6978-90efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-6978-60efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-6978-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-6978-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-6978-8ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-6978-9ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-6978-6ad56d346431e…cc804d4bbf1e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090939-001ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11
A090939-002ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11
A090939-003ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A090939-001AB
A090939-002AB
A090939-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090939-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090939-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090939-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090939-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090939-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090939-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090939-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090939-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090939-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090939-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090939-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090939-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090939-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090939-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090939-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090939-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090939-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090939-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090939-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090939-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090939-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090939-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090939-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090939-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090939-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090939-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090939-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090939-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A090939-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A090939-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090939-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090939-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090939-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090939-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090939-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090939-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090939-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090939-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090939-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090939-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-118072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090939-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090939-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090939-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090939-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090939-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090939-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090939-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090939-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090939-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090939-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090939-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090939-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090939-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090939-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090939-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090939-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090939-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090939-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090939-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090939-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090939-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090939-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090939-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090939-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090939-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090939-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090939-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090939-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090939-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090939-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090939-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090939-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090939-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090939-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090939-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090939-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090939-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090939-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090939-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090939-001AB18072bd15b7f6…

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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
escitalopramESCITALOPRAMPreferred Pharmaceuticals Inc.9ddd1f24-3ebd-4307-bb23-6acd742cd1402026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090939
application number: ANDA090939
escitalopramESCITALOPRAMBryant Ranch Prepack1d2f83c1-8ffe-48f3-a084-1502890017432026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090939
application number: ANDA090939
escitalopramESCITALOPRAMBryant Ranch Prepack5c00c4d3-8248-4321-adec-03886c0d0f7b2026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090939
application number: ANDA090939
escitalopram oxalateESCITALOPRAM OXALATEBryant Ranch Prepacka3a158a3-43ee-4b08-8171-e8c0d6ed0e662026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090939
application number: ANDA090939
escitalopramESCITALOPRAMCardinal Health 107, LLCcb3f9af4-5bb4-48a8-b972-ff92cff1ea012026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090939
application number: ANDA090939
escitalopram oxalateESCITALOPRAM OXALATEPreferred Pharmaceuticals Inc.7d924d16-8a10-411d-be57-97c450f56de72026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090939
application number: ANDA090939
escitalopramESCITALOPRAMBryant Ranch Prepacka0ff752d-cb30-4131-a7d6-cd66d8a47b1a2026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090939
application number: ANDA090939
escitalopramESCITALOPRAMBryant Ranch Prepackcb30d1c5-2280-465f-84f4-4367ad5f1a312026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090939
application number: ANDA090939
escitalopramESCITALOPRAMBryant Ranch Prepack0de88dad-d54c-4773-a5d6-a705e012973a2026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090939
application number: ANDA090939
escitalopramESCITALOPRAMMajor Pharmaceuticalsf4a12048-181e-45ed-a382-f53096d1b6892026-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090939
application number: ANDA090939
escitalopramESCITALOPRAMTorrent Pharmaceuticals Limited068bb338-23f3-4278-958b-c34b404560242026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090939
application number: ANDA090939
escitalopram oxalateESCITALOPRAM OXALATEPD-Rx Pharmaceuticals, Inc.b7670e51-8f44-4f64-b110-3f2f431a40322025-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090939
application number: ANDA090939
EscitalopramESCITALOPRAMDirect_Rxf6cacd68-0f55-deb9-e053-6294a90aa2662025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090939
application number: ANDA090939
escitalopram oxalateESCITALOPRAM OXALATEBryant Ranch Prepack86cfcd96-6397-42ef-8a79-f62706f0aca62024-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090939
application number: ANDA090939
escitalopram oxalateESCITALOPRAM OXALATEQuallent Pharmaceuticals Health LLCd8e22060-4d06-42bf-a881-caaf65ecc3e32024-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090939
application number: ANDA090939
escitalopram oxalateESCITALOPRAM OXALATEProficient Rx LP8201a719-7837-45fb-b991-4fcdbf006d242023-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090939
application number: ANDA090939
escitalopram oxalateESCITALOPRAM OXALATEProficient Rx LPe773030f-d07d-4bb8-9dc9-6f649688346d2020-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090939
application number: ANDA090939

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-6978-168788697801100 TABLET in 1 BOTTLE (68788-6978-1) 100 tablet2017-06-060000-00-00NoNoCurrent
68788-6978-36878869780330 TABLET in 1 BOTTLE (68788-6978-3) 30 tablet2017-06-060000-00-00NoNoCurrent
68788-6978-66878869780660 TABLET in 1 BOTTLE (68788-6978-6) 60 tablet2017-06-060000-00-00NoNoCurrent
68788-6978-86878869780828 TABLET in 1 BOTTLE (68788-6978-8) 28 tablet2017-06-060000-00-00NoNoCurrent
68788-6978-96878869780990 TABLET in 1 BOTTLE (68788-6978-9) 90 tablet2017-06-060000-00-00NoNoCurrent