Escitalopram

Product NDC
68180-135
Requested package NDC
68180-135-01
11-digit product format
681800135
Labeler code
68180
Product ID
68180-135_bd9ecc53-f6db-4750-8d73-6081cf03afa0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitslopram
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA078169
Marketing category
ANDA
Marketing start
2012-09-10
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
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68180-13568180-135-01DDiscontinued 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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
A078169-001ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11
A078169-002ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11
A078169-003ESCITALOPRAM 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
A078169-001AB
A078169-002AB
A078169-003AB

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 06:07:402026-07A078169-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A078169-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A078169-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078169-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078169-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078169-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078169-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078169-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078169-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078169-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078169-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078169-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078169-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078169-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078169-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078169-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078169-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078169-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078169-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078169-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078169-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078169-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078169-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078169-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078169-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078169-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078169-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078169-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078169-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078169-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078169-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A078169-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A078169-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078169-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078169-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078169-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078169-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078169-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078169-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078169-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-111e350fbaab3a…

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 06:07:402026-07A078169-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078169-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078169-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078169-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078169-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078169-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078169-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078169-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078169-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078169-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078169-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078169-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078169-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078169-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078169-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078169-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078169-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078169-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078169-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078169-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078169-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078169-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078169-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078169-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078169-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078169-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078169-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078169-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078169-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078169-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078169-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078169-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078169-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078169-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078169-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078169-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078169-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078169-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078169-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078169-001AB11e350fbaab3a…

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
68180-135-01Escitalopram100 in 1 BOTTLETABLET10021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-135-01EA - Each68180-1352e31a350-6070-4e58-8925-016d47f5342a12013-02-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-135ESCITALOPRAM (ESCITSLOPRAM) TABLET [LUPIN PHARMACEUTICALS, INC.]21Legacy NDC, 1 package rows20231219_41f7392a-1f5c-4542-9c5c-f9e109851381.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
EscitalopramESCITSLOPRAMLupin Pharmaceuticals, Inc.41f7392a-1f5c-4542-9c5c-f9e1098513812023-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078169
application number: ANDA078169
ndc (package): 68180-135-01
ndc (product): 68180-135
ndc11 (package): 68180013501

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN41f7392a-1f5c-4542-9c5c-f9e10985138121
351250escitalopram oxalate 20 MG Oral TabletPSN41f7392a-1f5c-4542-9c5c-f9e10985138121
351249escitalopram oxalate 5 MG Oral TabletPSN41f7392a-1f5c-4542-9c5c-f9e10985138121
349332escitalopram 10 MG Oral TabletSCD41f7392a-1f5c-4542-9c5c-f9e10985138121
351250escitalopram 20 MG Oral TabletSCD41f7392a-1f5c-4542-9c5c-f9e10985138121
351249escitalopram 5 MG Oral TabletSCD41f7392a-1f5c-4542-9c5c-f9e10985138121
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY41f7392a-1f5c-4542-9c5c-f9e10985138121
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY41f7392a-1f5c-4542-9c5c-f9e10985138121
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY41f7392a-1f5c-4542-9c5c-f9e10985138121
349332escitalopram oxalate 10 MG Oral TabletPSN25d450c1-932f-4f5e-b5f7-d3824d3c4efd1
349332escitalopram oxalate 10 MG Oral TabletPSNb61790d5-8913-413e-ab0a-f6da0ffdd5341
349332escitalopram 10 MG Oral TabletSCD25d450c1-932f-4f5e-b5f7-d3824d3c4efd1
349332escitalopram 10 MG Oral TabletSCDb61790d5-8913-413e-ab0a-f6da0ffdd5341
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY25d450c1-932f-4f5e-b5f7-d3824d3c4efd1
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYb61790d5-8913-413e-ab0a-f6da0ffdd5341

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-135-0168180013501100 TABLET in 1 BOTTLE (68180-135-01) 100 tablet2012-09-100000-00-00NoNoCurrent