escitalopram

Product NDC
68788-8723
11-digit product format
687888723
Labeler code
68788
Product ID
68788-8723_2240d9ee-2752-4509-923b-27f9eb816be6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078777
Marketing category
ANDA
Marketing start
2024-08-15
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
2027-12-31
Current FDA listing
Yes

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
A078777-001ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11
A078777-002ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11
A078777-003ESCITALOPRAM 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
A078777-001AB
A078777-002AB
A078777-003AB

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 06:07:402026-07A078777-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A078777-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A078777-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078777-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078777-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078777-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078777-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078777-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078777-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078777-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078777-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078777-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078777-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078777-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078777-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078777-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078777-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078777-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078777-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078777-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078777-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078777-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078777-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078777-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078777-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078777-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078777-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078777-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078777-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078777-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078777-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A078777-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A078777-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078777-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078777-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078777-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078777-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078777-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078777-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078777-001ESCITALOPRAM 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 06:07:402026-07A078777-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078777-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078777-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078777-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078777-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078777-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078777-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078777-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078777-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078777-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078777-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078777-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078777-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078777-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078777-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078777-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078777-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078777-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078777-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078777-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078777-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078777-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078777-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078777-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078777-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078777-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078777-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078777-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078777-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078777-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078777-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078777-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078777-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078777-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078777-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078777-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078777-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078777-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078777-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078777-001AB11e350fbaab3a…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESCITALOPRAM OXALATE20 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
351250Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eef1c681-1972-4c3f-b4ba-cbb3388f397aAvailable 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
68788-8723-1escitalopram100 in 1 BOTTLETABLET, FILM COATED1003
68788-8723-3escitalopram30 in 1 BOTTLETABLET, FILM COATED303
68788-8723-6escitalopram60 in 1 BOTTLETABLET, FILM COATED603
68788-8723-8escitalopram28 in 1 BOTTLETABLET, FILM COATED283
68788-8723-9escitalopram90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8723-1EA - Each68788-8723bb63bc82-83ec-4b85-9bab-40331a9e85bf12024-10-04
68788-8723-3EA - Each68788-872383db0138-1658-41bc-a96a-378c1ffbdcf412024-10-04
68788-8723-6EA - Each68788-8723d663f523-d8bb-477f-93f1-94bdbc822a6712024-10-04
68788-8723-8EA - Each68788-87239994f6ff-b601-468e-a937-2e28179affa512024-10-04
68788-8723-9EA - Each68788-872382a309f0-8522-4e85-8ae8-2658935992df12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8723ESCITALOPRAM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 5 package rows20250410_eef1c681-1972-4c3f-b4ba-cbb3388f397a.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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
escitalopramESCITALOPRAMSt. Mary's Medical Park Pharmacy1b2ec266-be5b-9265-e063-6294a90a10e32026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078777
application number: ANDA078777
escitalopramESCITALOPRAMREMEDYREPACK INC.76a8aedd-7853-4d3f-9a00-f8222f55bea82026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078777
application number: ANDA078777
escitalopramESCITALOPRAMPreferred Pharmaceuticals Inc.eef1c681-1972-4c3f-b4ba-cbb3388f397a2026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078777
application number: ANDA078777
ndc (product): 68788-8723
escitalopramESCITALOPRAMPreferred Pharmaceuticals Inc.d16a7510-c787-4c9b-818b-1ffbcc62b3c32026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078777
application number: ANDA078777
escitalopramESCITALOPRAMBryant Ranch Prepack64de12e0-c35f-4082-b902-ddbaee8158a62026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078777
application number: ANDA078777
escitalopramESCITALOPRAMREMEDYREPACK INC.d75e3b97-1ead-4e7b-9ae3-3626aede1efd2025-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078777
application number: ANDA078777
escitalopramESCITALOPRAMREMEDYREPACK INC.53a7e974-9945-4e42-8395-b567bf9f1c4e2025-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078777
application number: ANDA078777
escitalopramESCITALOPRAMST. MARY'S MEDICAL PARK PHARMACY362327ce-2dde-f657-e063-6394a90a0b632025-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078777
application number: ANDA078777
escitalopramESCITALOPRAMA-S Medication Solutions3965ca55-a5ff-4ed0-940c-363d74683fab2025-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078777
application number: ANDA078777
escitalopramESCITALOPRAMCoupler LLC2d54a1cf-29cd-c485-e063-6394a90aeba32025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078777
application number: ANDA078777
escitalopramESCITALOPRAMCoupler LLC2d58c448-4a6c-1b7d-e063-6294a90a7d032025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078777
application number: ANDA078777
escitalopramESCITALOPRAMBryant Ranch Prepack3ca5da44-403b-4c9f-9dde-f5a87866836d2024-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078777
application number: ANDA078777
escitalopramESCITALOPRAMBryant Ranch Prepack735a138b-fff3-4ed0-8a51-9090cf88ba302024-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078777
application number: ANDA078777
escitalopramESCITALOPRAMRising Pharma Holdings, Inc.ccbe97b5-da68-4fff-929a-240dd705fe6f2024-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078777
application number: ANDA078777

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351250escitalopram oxalate 20 MG Oral TabletPSNeef1c681-1972-4c3f-b4ba-cbb3388f397a3
351250escitalopram 20 MG Oral TabletSCDeef1c681-1972-4c3f-b4ba-cbb3388f397a3
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYeef1c681-1972-4c3f-b4ba-cbb3388f397a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8723-168788872301100 TABLET, FILM COATED in 1 BOTTLE (68788-8723-1) 2024-08-15NoNoCurrent
68788-8723-36878887230330 TABLET, FILM COATED in 1 BOTTLE (68788-8723-3) 2024-08-15NoNoCurrent
68788-8723-66878887230660 TABLET, FILM COATED in 1 BOTTLE (68788-8723-6) 2024-08-15NoNoCurrent
68788-8723-86878887230828 TABLET, FILM COATED in 1 BOTTLE (68788-8723-8) 2024-08-15NoNoCurrent
68788-8723-96878887230990 TABLET, FILM COATED in 1 BOTTLE (68788-8723-9) 2024-08-15NoNoCurrent