escitalopram

Product NDC
16571-757
11-digit product format
165710757
Labeler code
16571
Product ID
16571-757_9929f3a5-d78b-4d99-bf87-d2693a9ac47e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA078777
Marketing category
ANDA
Marketing start
2023-06-10
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
2026-12-31
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
2026-12-31

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349332Internal RxNorm lookup
351249Internal RxNorm lookup
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
ccbe97b5-da68-4fff-929a-240dd705fe6fAvailable 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
16571-757-01escitalopram100 in 1 BOTTLETABLET, FILM COATED1002
16571-757-10escitalopram1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-757-01EA - Each16571-7574985aa08-e56a-4eca-a610-0efde4165b8912023-07-06
16571-757-10EA - Each16571-75795823914-ea05-4cbf-983d-e497aa161ba412023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-757ESCITALOPRAM TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]2Current NDC, 2 package rows20241114_ccbe97b5-da68-4fff-929a-240dd705fe6f.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
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
ndc (product): 16571-757

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351250escitalopram oxalate 20 MG Oral TabletPSN735a138b-fff3-4ed0-8a51-9090cf88ba30101
351250escitalopram 20 MG Oral TabletSCD735a138b-fff3-4ed0-8a51-9090cf88ba30101
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY735a138b-fff3-4ed0-8a51-9090cf88ba30101
351250escitalopram oxalate 20 MG Oral TabletPSN53a7e974-9945-4e42-8395-b567bf9f1c4e4
351250escitalopram 20 MG Oral TabletSCD53a7e974-9945-4e42-8395-b567bf9f1c4e4
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY53a7e974-9945-4e42-8395-b567bf9f1c4e4
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
349332escitalopram oxalate 10 MG Oral TabletPSNccbe97b5-da68-4fff-929a-240dd705fe6f2
351250escitalopram oxalate 20 MG Oral TabletPSNccbe97b5-da68-4fff-929a-240dd705fe6f2
351249escitalopram oxalate 5 MG Oral TabletPSNccbe97b5-da68-4fff-929a-240dd705fe6f2
349332escitalopram 10 MG Oral TabletSCDccbe97b5-da68-4fff-929a-240dd705fe6f2
351250escitalopram 20 MG Oral TabletSCDccbe97b5-da68-4fff-929a-240dd705fe6f2
351249escitalopram 5 MG Oral TabletSCDccbe97b5-da68-4fff-929a-240dd705fe6f2
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYccbe97b5-da68-4fff-929a-240dd705fe6f2
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYccbe97b5-da68-4fff-929a-240dd705fe6f2
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSYccbe97b5-da68-4fff-929a-240dd705fe6f2
351250escitalopram oxalate 20 MG Oral TabletPSN2d58c448-4a6c-1b7d-e063-6294a90a7d031
351250escitalopram 20 MG Oral TabletSCD2d58c448-4a6c-1b7d-e063-6294a90a7d031
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY2d58c448-4a6c-1b7d-e063-6294a90a7d031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
16571-757-0116571075701100 TABLET, FILM COATED in 1 BOTTLE (16571-757-01) 2023-06-10NoNoCurrent
16571-757-10165710757101000 TABLET, FILM COATED in 1 BOTTLE (16571-757-10) 2023-06-10NoNoCurrent