Escitalopram Oral Solution

Product NDC
62135-729
11-digit product format
621350729
Labeler code
62135
Product ID
62135-729_2f987c95-695b-d900-e063-6294a90a0cf8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram Oral
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA090477
Marketing category
ANDA
Marketing start
2023-06-12
Substance
ESCITALOPRAM OXALATE
Active strength
5 mg/5mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090477-001ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090477-001AA

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-1287673890dc5c…
2021-03-12 10:30 UTC2021-03A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-123f01610625f2…
2019-09-15 20:21 UTC2019-09A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-12b00525d2431f…
2019-07-19 19:46 UTC2019-07A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-123f0d92c62455…
2023-05-13 08:27 UTC2023-05A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-12053a50430f4f…
2023-01-26 05:58 UTC2023-01A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090477-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2013-06-12e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090477-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090477-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090477-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090477-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090477-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090477-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090477-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090477-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090477-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090477-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090477-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090477-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090477-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090477-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090477-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090477-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090477-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090477-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090477-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090477-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090477-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090477-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A090477-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090477-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090477-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090477-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A090477-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090477-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090477-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090477-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090477-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090477-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090477-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090477-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090477-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090477-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090477-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090477-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090477-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090477-001AA1e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESCITALOPRAM OXALATE5 mg/5mL

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
351285Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0458445b-e431-4c82-86b8-90373813c10aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615Product name620170718
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-729-10Escitalopram Oral Solution10 mL in 1 CUPSOLUTION103
62135-729-24Escitalopram Oral Solution10 in 1 TRAYSOLUTION103
62135-729-24Escitalopram Oral Solution2 in 1 BOXSOLUTION23
62135-729-37Escitalopram Oral Solution240 mL in 1 BOTTLESOLUTION2403

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-729-10ML - Milliliter62135-7295a965ac6-3d98-44b7-a287-2b07b58b0de312025-05-14
62135-729-24ML - Milliliter62135-729dde72336-ad69-40c3-986c-0e2bc5a66f4512025-05-14
62135-729-37ML - Milliliter62135-7295f76c9fe-16dd-4a7f-97dd-0dfea10cd32d12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-729ESCITALOPRAM ORAL SOLUTION (ESCITALOPRAM ORAL) SOLUTION [CHARTWELL RX, LLC]3Current NDC, 4 package rows20250308_0458445b-e431-4c82-86b8-90373813c10a.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Escitalopram Oral SolutionESCITALOPRAM ORALChartwell Governmental & Specialty RX, LLC.45ed4d16-6358-40a1-9352-319e58f55e5d2026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090477
application number: ANDA090477
Escitalopram Oral SolutionESCITALOPRAM ORALChartwell RX, LLC0458445b-e431-4c82-86b8-90373813c10a2025-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090477
application number: ANDA090477
ndc (product): 62135-729

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351285escitalopram 5 MG in 5 mL Oral SolutionPSN0458445b-e431-4c82-86b8-90373813c10a3
351285escitalopram 1 MG/ML Oral SolutionSCD0458445b-e431-4c82-86b8-90373813c10a3
351285escitalopram (as escitalopram oxalate) 10 MG per 10 ML Oral SolutionSY0458445b-e431-4c82-86b8-90373813c10a3
351285escitalopram (as escitalopram oxalate) 5 MG per 5 ML Oral SolutionSY0458445b-e431-4c82-86b8-90373813c10a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-729-106213507291010 mL in 1 CUP10 mlHistorical
62135-729-24621350729242 TRAY in 1 BOX (62135-729-24) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-729-10) 2 tray2025-02-26NoNoCurrent
62135-729-3762135072937240 mL in 1 BOTTLE (62135-729-37) 240 ml2023-08-11NoNoCurrent