Escitalopram Oxalate

Product NDC
65862-248
11-digit product format
658620248
Labeler code
65862
Product ID
65862-248_a8ce07ef-c51d-4af2-bafb-b0a32c090431
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram Oxalate
Dosage form
SOLUTION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA079062
Marketing category
ANDA
Marketing start
2012-04-03
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
2027-12-31
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
A079062-001ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A079062-001AA

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 06:07:402026-07A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-023f01610625f2…
2019-09-15 20:21 UTC2019-09A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079062-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-04-02e64feba35796…

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 06:07:402026-07A079062-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079062-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079062-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A079062-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079062-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079062-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079062-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079062-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079062-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079062-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079062-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079062-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079062-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079062-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079062-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079062-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079062-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079062-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079062-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079062-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079062-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079062-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A079062-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079062-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079062-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079062-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A079062-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A079062-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079062-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079062-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079062-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079062-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079062-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079062-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079062-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A079062-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A079062-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079062-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079062-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079062-001AA1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Escitalopram Oxalate
Listing expiration
2027-12-31

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
ba60c357-8e61-4a3d-b1dc-25602dbbfc2aAvailable 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
65862-248-24Escitalopram Oxalate240 mL in 1 BOTTLESOLUTION24020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-248-24ML - Milliliter65862-248393a7f33-93a6-4662-829b-4fb83ace9f8412012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-248ESCITALOPRAM OXALATE SOLUTION [AUROBINDO PHARMA LIMITED]19Current NDC, Legacy NDC, 1 package rows20240521_ba60c357-8e61-4a3d-b1dc-25602dbbfc2a.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 OxalateESCITALOPRAM OXALATERising Pharma Holdings, Inc.79fddc2d-2dc2-444f-8fd3-0337090ee7442026-05-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079062
application number: ANDA079062
Escitalopram OxalateESCITALOPRAM OXALATEAurobindo Pharma Limitedba60c357-8e61-4a3d-b1dc-25602dbbfc2a2026-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079062
application number: ANDA079062
ndc (product): 65862-248

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351285escitalopram 5 MG in 5 mL Oral SolutionPSNba60c357-8e61-4a3d-b1dc-25602dbbfc2a20
351285escitalopram 1 MG/ML Oral SolutionSCDba60c357-8e61-4a3d-b1dc-25602dbbfc2a20
351285escitalopram (as escitalopram oxalate) 10 MG per 10 ML Oral SolutionSYba60c357-8e61-4a3d-b1dc-25602dbbfc2a20
351285escitalopram (as escitalopram oxalate) 5 MG per 5 ML Oral SolutionSYba60c357-8e61-4a3d-b1dc-25602dbbfc2a20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-248-2465862024824240 mL in 1 BOTTLE (65862-248-24) 240 ml2012-04-030000-00-00NoNoCurrent