Lexapro

Product NDC
33261-686
11-digit product format
332610686
Labeler code
33261
Product ID
33261-686_d73d3c7c-5e0c-43b7-992c-105eb90c7103
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESCITALOPRAM OXALATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
NDA021323
Marketing category
NDA
Marketing start
2002-08-14
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct33261-686IInactivated by FDA2026-08-17
excluded packagepackage33261-68633261-686-30IInactivated by FDA2026-08-17

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 · 42 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 packagepackage33261-686-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-686-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-686-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-686-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-686-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-686-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-686-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-686-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-686-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33261-686-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage33261-686-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage33261-686-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage33261-686-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage33261-686-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage33261-686-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage33261-686-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage33261-686-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage33261-686-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage33261-686-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage33261-686-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage33261-686-309bebd1f3094a…5416666fcb17…

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
N021323-001LEXAPROESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALABRLD2002-08-14
N021323-002LEXAPROESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALABRLD2002-08-14
N021323-003LEXAPROESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALABRLD, RS2002-08-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021323-001AB
N021323-002AB
N021323-003AB

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N021323-001NPP2026-05-12
N021323-002NPP2026-05-12
N021323-003NPP2026-05-12

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 06:07:402026-07N021323-001LEXAPROEQ 5MG BASETABLET / ORALABRLD2002-08-14caaa826d4ba7…
2026-08-18 06:07:402026-07N021323-002LEXAPROEQ 10MG BASETABLET / ORALABRLD2002-08-14caaa826d4ba7…
2026-08-18 06:07:402026-07N021323-003LEXAPROEQ 20MG BASETABLET / ORALABRLD, RS2002-08-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021323-001LEXAPROEQ 5MG BASETABLET / ORALABRLD2002-08-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021323-002LEXAPROEQ 10MG BASETABLET / ORALABRLD2002-08-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021323-003LEXAPROEQ 20MG BASETABLET / ORALABRLD, RS2002-08-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021323-001LEXAPROEQ 5MG BASETABLET / ORALABRLD2002-08-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021323-002LEXAPROEQ 10MG BASETABLET / ORALABRLD2002-08-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021323-003LEXAPROEQ 20MG BASETABLET / ORALABRLD, RS2002-08-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N021323-001LEXAPROEQ 5MG BASETABLET / ORALABRLD2002-08-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021323-002LEXAPROEQ 10MG BASETABLET / ORALABRLD2002-08-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021323-003LEXAPROEQ 20MG BASETABLET / ORALABRLD, RS2002-08-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021323-001LEXAPROEQ 5MG BASETABLET / ORALABRLD2002-08-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021323-002LEXAPROEQ 10MG BASETABLET / ORALABRLD2002-08-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021323-003LEXAPROEQ 20MG BASETABLET / ORALABRLD, RS2002-08-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021323-001LEXAPROEQ 5MG BASETABLET / ORALABRLD2002-08-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021323-002LEXAPROEQ 10MG BASETABLET / ORALABRLD2002-08-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021323-003LEXAPROEQ 20MG BASETABLET / ORALABRLD, RS2002-08-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021323-001LEXAPROEQ 5MG BASETABLET / ORALABRLD2002-08-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021323-002LEXAPROEQ 10MG BASETABLET / ORALABRLD2002-08-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021323-003LEXAPROEQ 20MG BASETABLET / ORALABRLD, RS2002-08-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021323-001LEXAPROEQ 5MG BASETABLET / ORALABRLD2002-08-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021323-002LEXAPROEQ 10MG BASETABLET / ORALABRLD2002-08-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021323-003LEXAPROEQ 20MG BASETABLET / ORALABRLD, RS2002-08-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021323-001LEXAPROEQ 5MG BASETABLET / ORALABRLD2002-08-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021323-002LEXAPROEQ 10MG BASETABLET / ORALABRLD2002-08-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021323-003LEXAPROEQ 20MG BASETABLET / ORALABRLD, RS2002-08-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021323-001LEXAPROEQ 5MG BASETABLET / ORALABRLD2002-08-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021323-002LEXAPROEQ 10MG BASETABLET / ORALABRLD2002-08-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021323-003LEXAPROEQ 20MG BASETABLET / ORALABRLD, RS2002-08-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021323-001LEXAPROEQ 5MG BASETABLET / ORALABRLD2002-08-14d06236e962d9…
2024-10-29 15:01 UTC2024-10N021323-002LEXAPROEQ 10MG BASETABLET / ORALABRLD2002-08-14d06236e962d9…
2024-10-29 15:01 UTC2024-10N021323-003LEXAPROEQ 20MG BASETABLET / ORALABRLD, RS2002-08-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021323-001LEXAPROEQ 5MG BASETABLET / ORALABRLD2002-08-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021323-002LEXAPROEQ 10MG BASETABLET / ORALABRLD2002-08-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021323-003LEXAPROEQ 20MG BASETABLET / ORALABRLD, RS2002-08-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021323-001LEXAPROEQ 5MG BASETABLET / ORALABRLD2002-08-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021323-002LEXAPROEQ 10MG BASETABLET / ORALABRLD2002-08-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021323-003LEXAPROEQ 20MG BASETABLET / ORALABRLD, RS2002-08-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021323-001LEXAPROEQ 5MG BASETABLET / ORALABRLD2002-08-141e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N021323-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021323-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021323-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021323-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021323-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021323-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021323-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021323-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021323-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021323-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021323-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021323-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021323-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021323-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021323-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021323-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021323-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021323-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021323-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021323-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021323-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021323-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021323-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021323-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021323-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021323-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021323-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021323-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021323-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021323-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021323-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021323-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021323-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021323-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021323-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021323-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021323-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021323-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021323-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021323-001AB11e350fbaab3a…

Observed Orange Book patent history#

Patent history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021323-00169169412022-08-12Drug substance, Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021323-00174200692022-08-12Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021323-0016916941*PED2023-02-12Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021323-0017420069*PED2023-02-12Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021323-00269169412022-08-12Drug substance, Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021323-00274200692022-08-12Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021323-0026916941*PED2023-02-12Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021323-0027420069*PED2023-02-12Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021323-00369169412022-08-12Drug substance, Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021323-00374200692022-08-12Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021323-0036916941*PED2023-02-12Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021323-0037420069*PED2023-02-12Pediatric extension5c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021323-00169169412022-08-12Drug substance, Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021323-00174200692022-08-12Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021323-0016916941*PED2023-02-12Pediatric extension5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021323-0017420069*PED2023-02-12Pediatric extension5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021323-00269169412022-08-12Drug substance, Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021323-00274200692022-08-12Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021323-0026916941*PED2023-02-12Pediatric extension5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021323-0027420069*PED2023-02-12Pediatric extension5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021323-00369169412022-08-12Drug substance, Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021323-00374200692022-08-12Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021323-0036916941*PED2023-02-12Pediatric extension5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021323-0037420069*PED2023-02-12Pediatric extension5d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021323-00169169412022-08-12Drug substance, Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021323-00174200692022-08-12Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021323-0016916941*PED2023-02-12Pediatric extension4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021323-0017420069*PED2023-02-12Pediatric extension4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021323-00269169412022-08-12Drug substance, Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021323-00274200692022-08-12Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021323-0026916941*PED2023-02-12Pediatric extension4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021323-0027420069*PED2023-02-12Pediatric extension4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021323-00369169412022-08-12Drug substance, Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021323-00374200692022-08-12Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021323-0036916941*PED2023-02-12Pediatric extension4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021323-0037420069*PED2023-02-12Pediatric extension4b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021323-00169169412022-08-12Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021323-00174200692022-08-12Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021323-0016916941*PED2023-02-12Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021323-0017420069*PED2023-02-12Pediatric extension74a2ff9319b5…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07N021323-001NPP2026-05-12caaa826d4ba7…
2026-08-18 06:07:402026-07N021323-002NPP2026-05-12caaa826d4ba7…
2026-08-18 06:07:402026-07N021323-003NPP2026-05-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021323-001NPP2026-05-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021323-002NPP2026-05-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021323-003NPP2026-05-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021323-001NPP2026-05-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021323-002NPP2026-05-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021323-003NPP2026-05-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08N021323-001NPP2026-05-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021323-002NPP2026-05-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021323-003NPP2026-05-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021323-001NPP2026-05-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021323-002NPP2026-05-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021323-003NPP2026-05-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021323-001NPP2026-05-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021323-002NPP2026-05-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021323-003NPP2026-05-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021323-001NPP2026-05-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021323-002NPP2026-05-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021323-003NPP2026-05-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021323-001NPP2026-05-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021323-002NPP2026-05-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021323-003NPP2026-05-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021323-001NPP2026-05-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021323-002NPP2026-05-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021323-003NPP2026-05-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021323-001NPP2026-05-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021323-002NPP2026-05-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021323-003NPP2026-05-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021323-001NPP2026-05-12d06236e962d9…
2024-10-29 15:01 UTC2024-10N021323-002NPP2026-05-12d06236e962d9…
2024-10-29 15:01 UTC2024-10N021323-003NPP2026-05-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021323-001NPP2026-05-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021323-002NPP2026-05-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021323-003NPP2026-05-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021323-001NPP2026-05-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021323-002NPP2026-05-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021323-003NPP2026-05-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021323-001NPP2026-05-121e350fbaab3a…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615Product name620170718

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-686-30Lexapro30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-686-30EA - Each33261-68699c1fb20-a58d-4c7a-9574-0b10da51460112015-10-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-686LEXAPRO (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20140110_16c67e3e-9928-4ad8-b850-84ec4d333e9b.zip

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LexaproESCITALOPRAMAllergan, Inc.13bb8267-1cab-43e5-acae-55a4d957630a2023-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021323
application number: NDA021323

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN16c67e3e-9928-4ad8-b850-84ec4d333e9b1
351250escitalopram oxalate 20 MG Oral TabletPSN16c67e3e-9928-4ad8-b850-84ec4d333e9b1
352272Lexapro 10 MG Oral TabletPSN16c67e3e-9928-4ad8-b850-84ec4d333e9b1
352273Lexapro 20 MG Oral TabletPSN16c67e3e-9928-4ad8-b850-84ec4d333e9b1
352272escitalopram 10 MG Oral Tablet [Lexapro]SBD16c67e3e-9928-4ad8-b850-84ec4d333e9b1
352273escitalopram 20 MG Oral Tablet [Lexapro]SBD16c67e3e-9928-4ad8-b850-84ec4d333e9b1
349332escitalopram 10 MG Oral TabletSCD16c67e3e-9928-4ad8-b850-84ec4d333e9b1
351250escitalopram 20 MG Oral TabletSCD16c67e3e-9928-4ad8-b850-84ec4d333e9b1
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY16c67e3e-9928-4ad8-b850-84ec4d333e9b1
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY16c67e3e-9928-4ad8-b850-84ec4d333e9b1
352272Lexapro (as escitalopram oxalate) 10 MG Oral TabletSY16c67e3e-9928-4ad8-b850-84ec4d333e9b1
352273Lexapro (as escitalopram oxalate) 20 MG Oral TabletSY16c67e3e-9928-4ad8-b850-84ec4d333e9b1
352272Lexapro 10 MG Oral TabletSY16c67e3e-9928-4ad8-b850-84ec4d333e9b1
352273Lexapro 20 MG Oral TabletSY16c67e3e-9928-4ad8-b850-84ec4d333e9b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-686-303326106863030 in 1 BOTTLE, PLASTICHistorical