Escitalopram

Product NDC
50090-5312
11-digit product format
500905312
Labeler code
50090
Product ID
50090-5312_5d70869d-59cb-4cbe-80a1-0b4106c4eab0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078032
Marketing category
ANDA
Marketing start
2016-02-01
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
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 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
9b0b3c54-5bbc-4db9-9c69-00dac1347f24Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615Product name620170718

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5312-0Escitalopram90 in 1 BOTTLETABLET, FILM COATED905
50090-5312-1Escitalopram30 in 1 BOTTLETABLET, FILM COATED305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5312-0EA - Each50090-53127f2b4f7f-8e08-4b69-ab74-d12c812778ba12023-08-08
50090-5312-1EA - Each50090-531284de769b-b8d0-4cba-9ba9-f2b12881863912023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5312ESCITALOPRAM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20230725_9b0b3c54-5bbc-4db9-9c69-00dac1347f24.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
351249escitalopram oxalate 5 MG Oral TabletPSN9b0b3c54-5bbc-4db9-9c69-00dac1347f245
351249escitalopram 5 MG Oral TabletSCD9b0b3c54-5bbc-4db9-9c69-00dac1347f245
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY9b0b3c54-5bbc-4db9-9c69-00dac1347f245

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5312-05009053120090 TABLET, FILM COATED in 1 BOTTLE (50090-5312-0) 2020-10-290000-00-00NoNoCurrent
50090-5312-15009053120130 TABLET, FILM COATED in 1 BOTTLE (50090-5312-1) 2023-07-13NoNoCurrent