Escitalopram

Product NDC
71335-1241
11-digit product format
713351241
Labeler code
71335
Product ID
71335-1241_f7726916-4977-46dc-bb0d-4de18473548b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078032
Marketing category
ANDA
Marketing start
2016-02-01
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
2026-12-31
Current FDA listing
Yes

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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71335-1241DDiscontinued by firm2026-08-17
excluded productproduct71335-1241DDiscontinued by firm2026-08-17
excluded packagepackage71335-124171335-1241-1DDiscontinued by firm2026-08-17
excluded packagepackage71335-124171335-1241-2DDiscontinued by firm2026-08-17
excluded packagepackage71335-124171335-1241-3DDiscontinued by firm2026-08-17
excluded packagepackage71335-124171335-1241-1DDiscontinued by firm2026-08-17
excluded packagepackage71335-124171335-1241-2DDiscontinued by firm2026-08-17
excluded packagepackage71335-124171335-1241-3DDiscontinued 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 · 96 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 productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1241-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1241-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1241-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1241-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1241-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1241-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1241-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1241-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1241-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1241-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1241-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1241-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1241-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1241-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1241-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1241-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1241-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1241-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1241-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1241-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1241-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1241-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1241-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1241-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1241-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1241-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1241-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1241-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1241-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1241-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1241-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1241-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1241-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1241-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1241-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1241-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1241-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1241-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1241-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1241-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1241-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1241-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1241-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1241-3ed331223b511…672a5bd82f5f…

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
A078032-001ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-28
A078032-002ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-28
A078032-003ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078032-001AB
A078032-002AB
A078032-003AB

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-281e350fbaab3a…

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 06:07:402026-07A078032-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078032-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078032-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078032-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078032-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078032-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078032-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078032-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078032-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078032-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078032-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078032-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078032-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078032-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078032-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078032-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078032-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078032-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078032-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078032-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078032-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078032-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078032-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078032-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078032-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078032-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078032-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078032-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078032-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078032-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078032-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078032-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078032-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078032-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078032-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078032-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078032-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078032-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078032-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078032-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Escitalopram
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESCITALOPRAM OXALATE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5U85DBW7LOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
351249Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
20281fe6-7db9-4b33-8418-b25e6a5404caAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615Product name620170718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1241-1Escitalopram30 in 1 BOTTLETABLET, FILM COATED30103
71335-1241-2Escitalopram60 in 1 BOTTLETABLET, FILM COATED60103
71335-1241-3Escitalopram90 in 1 BOTTLETABLET, FILM COATED90103
71335-1241-4Escitalopram100 in 1 BOTTLETABLET, FILM COATED100103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1241ESCITALOPRAM TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 4 package rows20240407_20281fe6-7db9-4b33-8418-b25e6a5404ca.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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EscitalopramESCITALOPRAMBryant Ranch Prepack20281fe6-7db9-4b33-8418-b25e6a5404ca2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
ndc (product): 71335-1241
EscitalopramESCITALOPRAMBluePoint Laboratoriesd31c02d0-81d9-4aa4-bde9-52135aa5a66d2026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMREMEDYREPACK INC.83fb7392-087d-4284-b27b-fa192e49dc212026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMREMEDYREPACK INC.b6fbd554-9da7-40fd-87a5-2c4af2aa3e6c2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMREMEDYREPACK INC.83a642b9-acee-45d3-95a1-52a491b770fd2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMSOLCO HEALTHCARE US, LLC155e973a-f4ff-4e5a-b937-09f1e106fe392026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMCoupler LLC5088d6cd-ec13-384d-e063-6394a90aee052026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMPreferred Pharmaceuticals, Inc.3e3a3e36-fb2f-4d9b-bbcf-423bd97c9f882026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMDirect_Rxf435d670-87ff-f226-e053-2a95a90ac0ee2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMA-S Medication Solutionsba6a0c20-4915-4164-a39e-ca67d652cbfd2026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMA-S Medication Solutionsa0344290-6e12-46c4-a11c-5347a770adbe2026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMREMEDYREPACK INC.0ef807d2-5d66-40c2-be3e-ff6176a352952026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMNorthwind Health Company, LLCf2b3b385-658d-5918-e053-2a95a90afcba2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMNorthwind Health Company, LLCf2b7b0a6-481b-1f6f-e053-2a95a90a2d042026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMNorthwind Health Company, LLCaddccf96-cc60-6045-e053-2a95a90aaac02026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMDirect_Rxf81e3858-f01e-1df6-e053-6394a90aef4f2025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMQPharma, Inc.e56e8d41-188c-5a6f-e053-2a95a90a70e62025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMQPharma, Inc.f682f991-1807-176a-e053-2995a90a3dfa2025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMAmerican Health Packagingde803217-6d32-4ef8-afe7-02462f37bf0c2025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMRedPharm Drug, Inc.fc61822a-4058-343c-e053-6294a90af72c2025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351249escitalopram oxalate 5 MG Oral TabletPSN20281fe6-7db9-4b33-8418-b25e6a5404ca103
351249escitalopram 5 MG Oral TabletSCD20281fe6-7db9-4b33-8418-b25e6a5404ca103
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY20281fe6-7db9-4b33-8418-b25e6a5404ca103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1241-17133512410130 TABLET, FILM COATED in 1 BOTTLE (71335-1241-1) 2019-07-020000-00-00NoNoCurrent
71335-1241-27133512410260 TABLET, FILM COATED in 1 BOTTLE (71335-1241-2) 2024-04-030000-00-00NoNoCurrent
71335-1241-37133512410390 TABLET, FILM COATED in 1 BOTTLE (71335-1241-3) 2019-06-040000-00-00NoNoCurrent
71335-1241-471335124104100 TABLET, FILM COATED in 1 BOTTLE (71335-1241-4) 2024-04-03NoNoCurrent