Escitalopram Oxalate

Product NDC
69097-848
11-digit product format
690970848
Labeler code
69097
Product ID
69097-848_7e44336f-9692-42ff-af45-f98edd0c803c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA078604
Marketing category
ANDA
Marketing start
2016-06-16
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
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
A078604-001ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11
A078604-002ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11
A078604-003ESCITALOPRAM 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
A078604-001AB
A078604-002AB
A078604-003AB

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 06:07:402026-07A078604-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A078604-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A078604-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078604-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078604-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078604-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078604-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078604-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078604-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078604-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078604-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078604-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078604-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078604-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078604-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078604-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078604-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078604-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078604-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078604-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078604-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078604-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078604-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078604-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078604-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078604-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078604-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078604-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078604-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078604-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078604-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A078604-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A078604-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078604-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078604-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078604-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078604-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078604-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078604-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078604-001ESCITALOPRAM 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 06:07:402026-07A078604-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078604-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078604-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078604-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078604-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078604-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078604-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078604-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078604-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078604-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078604-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078604-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078604-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078604-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078604-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078604-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078604-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078604-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078604-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078604-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078604-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078604-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078604-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078604-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078604-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078604-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078604-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078604-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078604-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078604-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078604-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078604-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078604-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078604-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078604-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078604-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078604-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078604-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078604-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078604-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Escitalopram Oxalate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESCITALOPRAM OXALATE10 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
31ce0b82-58fe-44f3-8887-c55d8df1b773Available 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
69097-848-02Escitalopram Oxalate30 in 1 BOTTLETABLET, FILM COATED3012
69097-848-05Escitalopram Oxalate90 in 1 BOTTLETABLET, FILM COATED9012
69097-848-07Escitalopram Oxalate100 in 1 BOTTLETABLET, FILM COATED10012
69097-848-12Escitalopram Oxalate500 in 1 BOTTLETABLET, FILM COATED50012
69097-848-15Escitalopram Oxalate1000 in 1 BOTTLETABLET, FILM COATED100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-848-05EA - Each69097-848e59dba36-2c3e-4f5d-afbd-151e88d17bd112016-07-19
69097-848-15EA - Each69097-8487cebe079-7c47-456f-b0e0-51c15bef382812024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-848ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [CIPLA USA INC.]11Current NDC, Legacy NDC, 5 package rows20240831_31ce0b82-58fe-44f3-8887-c55d8df1b773.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Escitalopram OxalateESCITALOPRAMREMEDYREPACK INC.4508226c-5623-41d3-8916-5f94ffdb88392026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078604
application number: ANDA078604
Escitalopram OxalateESCITALOPRAMLegacy Pharmaceutical Packaging, LLC9c68f89b-1d34-4735-9631-817f012935d72026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078604
application number: ANDA078604
Escitalopram OxalateESCITALOPRAMCipla USA Inc.31ce0b82-58fe-44f3-8887-c55d8df1b7732025-10-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078604
application number: ANDA078604
ndc (product): 69097-848
Escitalopram oxalateESCITALOPRAMExelan Pharmaceuticals Inc.8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd22024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078604
application number: ANDA078604
Escitalopram oxalateESCITALOPRAMAphena Pharma Solutions - Tennessee, LLC900b7a2f-23e7-4c78-bd6e-549bbe09883e2021-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078604
application number: ANDA078604

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN9c68f89b-1d34-4735-9631-817f012935d713
351250escitalopram oxalate 20 MG Oral TabletPSN9c68f89b-1d34-4735-9631-817f012935d713
349332escitalopram 10 MG Oral TabletSCD9c68f89b-1d34-4735-9631-817f012935d713
351250escitalopram 20 MG Oral TabletSCD9c68f89b-1d34-4735-9631-817f012935d713
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY9c68f89b-1d34-4735-9631-817f012935d713
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY9c68f89b-1d34-4735-9631-817f012935d713
349332escitalopram oxalate 10 MG Oral TabletPSN31ce0b82-58fe-44f3-8887-c55d8df1b77312
351250escitalopram oxalate 20 MG Oral TabletPSN31ce0b82-58fe-44f3-8887-c55d8df1b77312
351249escitalopram oxalate 5 MG Oral TabletPSN31ce0b82-58fe-44f3-8887-c55d8df1b77312
349332escitalopram 10 MG Oral TabletSCD31ce0b82-58fe-44f3-8887-c55d8df1b77312
351250escitalopram 20 MG Oral TabletSCD31ce0b82-58fe-44f3-8887-c55d8df1b77312
351249escitalopram 5 MG Oral TabletSCD31ce0b82-58fe-44f3-8887-c55d8df1b77312
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY31ce0b82-58fe-44f3-8887-c55d8df1b77312
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY31ce0b82-58fe-44f3-8887-c55d8df1b77312
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY31ce0b82-58fe-44f3-8887-c55d8df1b77312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69097-848-026909708480230 TABLET, FILM COATED in 1 BOTTLE (69097-848-02) 2016-06-160000-00-00NoNoCurrent
69097-848-056909708480590 TABLET, FILM COATED in 1 BOTTLE (69097-848-05) 2016-06-160000-00-00NoNoCurrent
69097-848-0769097084807100 TABLET, FILM COATED in 1 BOTTLE (69097-848-07) 2016-06-160000-00-00NoNoCurrent
69097-848-1269097084812500 TABLET, FILM COATED in 1 BOTTLE (69097-848-12) 2016-06-160000-00-00NoNoCurrent
69097-848-15690970848151000 TABLET, FILM COATED in 1 BOTTLE (69097-848-15) 2016-06-160000-00-00NoNoCurrent