Escitalopram

Product NDC
71205-168
11-digit product format
712050168
Labeler code
71205
Product ID
71205-168_bfd7c6f5-24c7-4491-b4f8-d501a2393fec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram Oxalate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090432
Marketing category
ANDA
Marketing start
2012-09-11
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
A090432-001ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11
A090432-002ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11
A090432-003ESCITALOPRAM 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
A090432-001AB
A090432-002AB
A090432-003AB

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 06:07:402026-07A090432-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A090432-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A090432-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090432-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090432-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090432-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090432-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090432-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090432-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090432-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090432-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090432-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090432-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090432-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090432-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090432-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090432-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090432-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090432-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090432-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090432-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090432-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090432-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090432-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090432-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090432-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090432-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090432-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090432-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090432-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090432-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A090432-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A090432-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090432-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090432-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090432-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090432-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090432-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090432-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090432-001ESCITALOPRAM 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 06:07:402026-07A090432-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090432-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090432-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090432-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090432-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090432-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090432-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090432-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090432-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090432-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090432-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090432-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090432-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090432-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090432-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090432-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090432-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090432-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090432-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090432-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090432-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090432-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090432-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090432-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090432-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090432-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090432-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090432-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090432-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090432-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090432-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090432-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090432-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090432-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090432-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090432-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090432-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090432-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090432-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090432-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Escitalopram
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349332Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2d0b4839-e4d1-4e0e-9dc0-ba821f266472Available 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
71205-168-30Escitalopram30 in 1 BOTTLETABLET, FILM COATED304
71205-168-60Escitalopram60 in 1 BOTTLETABLET, FILM COATED604
71205-168-90Escitalopram90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-168-30EA - Each71205-1682ec4f678-34dc-403d-a169-dec6f1899d1012021-03-02
71205-168-60EA - Each71205-1689dd672b0-854f-459a-8f14-0c01d7d91db912019-11-12
71205-168-90EA - Each71205-16870f37f0f-5080-4423-b9bb-d82eac10002012019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-168ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20220421_2d0b4839-e4d1-4e0e-9dc0-ba821f266472.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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EscitalopramESCITALOPRAM OXALATEPD-Rx Pharmaceuticals, Inc.517a551a-6f60-4b8d-9341-63a41baff12d2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
EscitalopramESCITALOPRAM OXALATEBryant Ranch Prepackee5963ad-3b53-48e5-b7a9-b13af5740ef12026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
EscitalopramESCITALOPRAM OXALATESt. Mary's Medical Park Pharmacy09945404-e4cf-6269-e063-6294a90a5b8d2026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
EscitalopramESCITALOPRAM OXALATEAurobindo Pharma Limitedd5fbc8ce-bd41-4bd0-b413-0dea97e596c32026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
EscitalopramESCITALOPRAM OXALATEAsclemed USA, Inc.2957a003-7714-4e16-aeca-623fd6c5d7022026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
EscitalopramESCITALOPRAM OXALATENorthwind Health Company, LLCf6ca64ec-68ff-e1ea-e053-6294a90ae0f82026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
EscitalopramESCITALOPRAM OXALATEQPharma, Inc.85fbcce8-a870-4f04-8a0e-a12e46eed3cf2025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
EscitalopramESCITALOPRAM OXALATEAmerican Health Packaging3019a647-9bcf-48cf-928c-0467f9b921a82025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
EscitalopramESCITALOPRAM OXALATENCS HealthCare of KY, LLC dba Vangard Labsb29ae169-d60b-464a-9763-f1d8d9e0598d2025-01-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
EscitalopramESCITALOPRAM OXALATEA-S Medication Solutionsb85ef018-0217-4ddf-885d-206acc0a5f842024-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
EscitalopramESCITALOPRAM OXALATEAdvanced Rx Pharmacy of Tennessee, LLC138f8703-2f13-6d07-e063-6394a90a44132024-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
EscitalopramESCITALOPRAM OXALATENCS HealthCare of KY, LLC dba Vangard Labsac9ede0c-7912-4e7d-83b3-964feee612152023-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
EscitalopramESCITALOPRAM OXALATEA-S Medication Solutions10b25a10-c5e7-479b-a9f5-7eeafd8023232023-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
EscitalopramESCITALOPRAM OXALATEProficient Rx LP52df055d-b1c8-4de2-8545-ef08b5bf9c392022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
EscitalopramESCITALOPRAM OXALATEProficient Rx LP2d0b4839-e4d1-4e0e-9dc0-ba821f2664722022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090432
application number: ANDA090432
ndc (product): 71205-168

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN2d0b4839-e4d1-4e0e-9dc0-ba821f2664724
349332escitalopram 10 MG Oral TabletSCD2d0b4839-e4d1-4e0e-9dc0-ba821f2664724
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY2d0b4839-e4d1-4e0e-9dc0-ba821f2664724

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-168-307120501683030 TABLET, FILM COATED in 1 BOTTLE (71205-168-30) 2012-09-110000-00-00NoNoCurrent
71205-168-607120501686060 TABLET, FILM COATED in 1 BOTTLE (71205-168-60) 2012-09-110000-00-00NoNoCurrent
71205-168-907120501689090 TABLET, FILM COATED in 1 BOTTLE (71205-168-90) 2012-09-110000-00-00NoNoCurrent