Escitalopram

Product NDC
71335-2058
11-digit product format
713352058
Labeler code
71335
Product ID
71335-2058_7b6a542f-766f-4e93-af3e-8ba3714b0b4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202389
Marketing category
ANDA
Marketing start
2013-03-05
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A202389-001ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11
A202389-002ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11
A202389-003ESCITALOPRAM 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
A202389-001AB
A202389-002AB
A202389-003AB

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202389-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1184e616aacf4f…
2026-09-14 22:38:342026-08A202389-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-1184e616aacf4f…
2026-09-14 22:38:342026-08A202389-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-1184e616aacf4f…
2026-08-18 06:07:402026-07A202389-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A202389-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A202389-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202389-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202389-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202389-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202389-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202389-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202389-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202389-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202389-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202389-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202389-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202389-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202389-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202389-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202389-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202389-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202389-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202389-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202389-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202389-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202389-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202389-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202389-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202389-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202389-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202389-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202389-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202389-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202389-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A202389-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A202389-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202389-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202389-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202389-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202389-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A202389-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A202389-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A202389-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A202389-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202389-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202389-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202389-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202389-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202389-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202389-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202389-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202389-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202389-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202389-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202389-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202389-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202389-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202389-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202389-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202389-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202389-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202389-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202389-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202389-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202389-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202389-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202389-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202389-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202389-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202389-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202389-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202389-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202389-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202389-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202389-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202389-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202389-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202389-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202389-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202389-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
43eb9e4f-1a46-46f7-9e9d-43e866963b37Available 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
71335-2058-1Escitalopram30 in 1 BOTTLETABLET, FILM COATED30103
71335-2058-2Escitalopram60 in 1 BOTTLETABLET, FILM COATED60103
71335-2058-3Escitalopram90 in 1 BOTTLETABLET, FILM COATED90103
71335-2058-4Escitalopram100 in 1 BOTTLETABLET, FILM COATED100103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2058ESCITALOPRAM TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 4 package rows20250226_43eb9e4f-1a46-46f7-9e9d-43e866963b37.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EscitalopramESCITALOPRAMBryant Ranch Prepack43eb9e4f-1a46-46f7-9e9d-43e866963b372026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202389
application number: ANDA202389
ndc (product): 71335-2058
EscitalopramESCITALOPRAMPD-Rx Pharmaceuticals, Inc.2d125ea4-5430-5b4e-e054-00144ff88e882026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202389
application number: ANDA202389
EscitalopramESCITALOPRAMPD-Rx Pharmaceuticals, Inc.83510549-bd47-4969-aba0-c149a0fbb7f32026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202389
application number: ANDA202389
EscitalopramESCITALOPRAMNorthwind Health Company, LLCd9ba6c65-22bd-10c4-e053-2995a90ada2e2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202389
application number: ANDA202389
EscitalopramESCITALOPRAMNorthwind Health Company, LLCdabf8bc0-5de6-edce-e053-2995a90a73c92026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202389
application number: ANDA202389
EscitalopramESCITALOPRAMNorthwind Health Company, LLCc9f52332-8616-19d8-e053-2995a90ad7532026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202389
application number: ANDA202389
EscitalopramESCITALOPRAMNorthwind Health Company, LLCda7feb56-5f5a-7487-e053-2995a90a119e2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202389
application number: ANDA202389
EscitalopramESCITALOPRAMAccord Healthcare Inc.84b2028d-eff4-434d-b71e-6a3c0812f6252025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202389
application number: ANDA202389
EscitalopramESCITALOPRAMBryant Ranch Prepackd143ec01-9445-42d5-a259-b0b5a7f9445f2025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202389
application number: ANDA202389
EscitalopramESCITALOPRAMBryant Ranch Prepack4966fd83-ee96-4f87-beb1-dd40d70de4452025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202389
application number: ANDA202389
EscitalopramESCITALOPRAMNuCare Pharmaceuticals, Inc.4a645652-ae1f-3811-e054-00144ff8d46c2024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202389
application number: ANDA202389
EscitalopramESCITALOPRAMNuCare Pharmaceuticals,Inc.8e88bc86-d5e2-50ca-e053-2995a90a0f0e2024-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202389
application number: ANDA202389
EscitalopramESCITALOPRAMA-S Medication Solutions16a07596-2a89-4897-a829-529452ceb1e82023-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202389
application number: ANDA202389
EscitalopramESCITALOPRAMProficient Rx LP1df5c652-7bad-4b07-b33b-333071bc26702023-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202389
application number: ANDA202389
EscitalopramESCITALOPRAMProficient Rx LP2fb28a40-037a-49a0-b418-6c6841885cf42022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202389
application number: ANDA202389
EscitalopramESCITALOPRAMAphena Pharma Solutions - Tennessee, LLC85b2f57e-53f3-4b93-9128-ad74cc34be4c2020-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202389
application number: ANDA202389

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351249escitalopram oxalate 5 MG Oral TabletPSN43eb9e4f-1a46-46f7-9e9d-43e866963b37104
351249escitalopram 5 MG Oral TabletSCD43eb9e4f-1a46-46f7-9e9d-43e866963b37104
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY43eb9e4f-1a46-46f7-9e9d-43e866963b37104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2058-17133520580130 TABLET, FILM COATED in 1 BOTTLE (71335-2058-1) 2022-06-300000-00-00NoNoCurrent
71335-2058-27133520580260 TABLET, FILM COATED in 1 BOTTLE (71335-2058-2) 2025-01-310000-00-00NoNoCurrent
71335-2058-37133520580390 TABLET, FILM COATED in 1 BOTTLE (71335-2058-3) 2022-03-040000-00-00NoNoCurrent
71335-2058-471335205804100 TABLET, FILM COATED in 1 BOTTLE (71335-2058-4) 2025-01-310000-00-00NoNoCurrent