Escitalopram

Product NDC
0093-5850
11-digit product format
000935850
Labeler code
0093
Product ID
0093-5850_c4634b47-1b92-4acf-bbb2-01241d18989b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA076765
Marketing category
ANDA
Marketing start
2012-03-14
Marketing end
2021-11-30
Substance
ESCITALOPRAM OXALATE
Active strength
5 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

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0093-5850DDiscontinued by firm2026-08-17
excluded packagepackage0093-58500093-5850-01DDiscontinued by firm2026-08-17
excluded packagepackage0093-58500093-5850-05DDiscontinued 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 1 · 36 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 packagepackage0093-5850-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0093-5850-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0093-5850-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0093-5850-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0093-5850-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0093-5850-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0093-5850-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0093-5850-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0093-5850-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0093-5850-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0093-5850-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0093-5850-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0093-5850-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0093-5850-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0093-5850-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0093-5850-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0093-5850-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0093-5850-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0093-5850-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0093-5850-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0093-5850-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0093-5850-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0093-5850-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0093-5850-01557ba5c1ecfa…9c80585c8c6e…

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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-5850-01EA - Each0093-5850b8c6b0a8-eb78-4352-ad6a-3aebc7fc947a12012-07-24
0093-5850-05EA - Each0093-58504e0f258d-f372-4340-b10b-84a789467f4d12012-07-24
0093-5850-19EA - Each0093-585091f92347-a162-4de5-a7c4-69db5d2bd15a12012-07-24
0093-5850-93EA - Each0093-5850706922f9-b877-4d19-ad8a-1616b361faff12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESCITALOPRAM OXALATEACTIVE INGREDIENT5U85DBW7LOESCITALOPRAM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
ESCITALOPRAMACTIVE MOIETY4O4S742ANYESCITALOPRAM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESCITALOPRAM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ESCITALOPRAM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WESCITALOPRAM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESCITALOPRAM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
MANNITOLINACTIVE INGREDIENT3OWL53L36AESCITALOPRAM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEESCITALOPRAM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJESCITALOPRAM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESCITALOPRAM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
ESCITALOPRAM OXALATEACTIVE INGREDIENT5U85DBW7LOESCITALOPRAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
ESCITALOPRAMACTIVE MOIETY4O4S742ANYESCITALOPRAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESCITALOPRAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ESCITALOPRAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WESCITALOPRAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESCITALOPRAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
MANNITOLINACTIVE INGREDIENT3OWL53L36AESCITALOPRAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEESCITALOPRAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJESCITALOPRAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESCITALOPRAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-5850-0100093585001100 TABLET, FILM COATED in 1 BOTTLE (0093-5850-01) 2012-03-142021-11-30NoNoCurrent
0093-5850-0500093585005500 TABLET, FILM COATED in 1 BOTTLE (0093-5850-05) 2012-03-142021-10-31NoNoCurrent