Escitalopram

Product NDC
71205-782
11-digit product format
712050782
Labeler code
71205
Product ID
71205-782_3e3de8ea-b96b-456b-9336-69380fd2d058
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078032
Marketing category
ANDA
Marketing start
2012-03-15
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
A078032-001ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-28
A078032-002ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-28
A078032-003ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A078032-001AB
A078032-002AB
A078032-003AB

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 06:07:402026-07A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-281e350fbaab3a…

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 06:07:402026-07A078032-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078032-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078032-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078032-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078032-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078032-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078032-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078032-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078032-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078032-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078032-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078032-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078032-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078032-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078032-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078032-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078032-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078032-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078032-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078032-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078032-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078032-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078032-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078032-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078032-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078032-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078032-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078032-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078032-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078032-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078032-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078032-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078032-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078032-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078032-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078032-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078032-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078032-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078032-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078032-001AB11e350fbaab3a…

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
3e3de8ea-b96b-456b-9336-69380fd2d058Available 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
71205-782-30Escitalopram30 in 1 BOTTLETABLET, FILM COATED301
71205-782-60Escitalopram60 in 1 BOTTLETABLET, FILM COATED601
71205-782-90Escitalopram90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-782-30EA - Each71205-7821704e520-640d-4cb8-88f0-289f39dd1f4a12023-08-08
71205-782-60EA - Each71205-7829be2cbcc-00ea-47d0-971b-43e6aaeb97be12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-782ESCITALOPRAM TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, 3 package rows20230401_3e3de8ea-b96b-456b-9336-69380fd2d058.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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EscitalopramESCITALOPRAMBryant Ranch Prepack20281fe6-7db9-4b33-8418-b25e6a5404ca2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMBluePoint Laboratoriesd31c02d0-81d9-4aa4-bde9-52135aa5a66d2026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMREMEDYREPACK INC.83fb7392-087d-4284-b27b-fa192e49dc212026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMREMEDYREPACK INC.b6fbd554-9da7-40fd-87a5-2c4af2aa3e6c2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMREMEDYREPACK INC.83a642b9-acee-45d3-95a1-52a491b770fd2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMSOLCO HEALTHCARE US, LLC155e973a-f4ff-4e5a-b937-09f1e106fe392026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMCoupler LLC5088d6cd-ec13-384d-e063-6394a90aee052026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMPreferred Pharmaceuticals, Inc.3e3a3e36-fb2f-4d9b-bbcf-423bd97c9f882026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMDirect_Rxf435d670-87ff-f226-e053-2a95a90ac0ee2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMA-S Medication Solutionsba6a0c20-4915-4164-a39e-ca67d652cbfd2026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMA-S Medication Solutionsa0344290-6e12-46c4-a11c-5347a770adbe2026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMREMEDYREPACK INC.0ef807d2-5d66-40c2-be3e-ff6176a352952026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMNorthwind Health Company, LLCf2b3b385-658d-5918-e053-2a95a90afcba2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMNorthwind Health Company, LLCf2b7b0a6-481b-1f6f-e053-2a95a90a2d042026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMNorthwind Health Company, LLCaddccf96-cc60-6045-e053-2a95a90aaac02026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMDirect_Rxf81e3858-f01e-1df6-e053-6394a90aef4f2025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMQPharma, Inc.e56e8d41-188c-5a6f-e053-2a95a90a70e62025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMQPharma, Inc.f682f991-1807-176a-e053-2995a90a3dfa2025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMAmerican Health Packagingde803217-6d32-4ef8-afe7-02462f37bf0c2025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMRedPharm Drug, Inc.fc61822a-4058-343c-e053-6294a90af72c2025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN3e3de8ea-b96b-456b-9336-69380fd2d0581
349332escitalopram 10 MG Oral TabletSCD3e3de8ea-b96b-456b-9336-69380fd2d0581
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY3e3de8ea-b96b-456b-9336-69380fd2d0581

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-782-307120507823030 TABLET, FILM COATED in 1 BOTTLE (71205-782-30) 2023-03-28NoNoCurrent
71205-782-607120507826060 TABLET, FILM COATED in 1 BOTTLE (71205-782-60) 2023-03-28NoNoCurrent
71205-782-907120507829090 TABLET, FILM COATED in 1 BOTTLE (71205-782-90) 2023-03-28NoNoCurrent