FDA.reportPublic FDA data

escitalopram

Product NDC
52427-795
11-digit product format
524270795
Labeler code
52427
Product ID
52427-795_4caf6d36-950a-522b-5914-079783778c6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram
Dosage form
CAPSULE
Route
ORAL
Labeler
Almatica Pharma LLC
Application
NDA219130
Marketing category
NDA
Marketing start
2025-10-06
Substance
ESCITALOPRAM OXALATE
Active strength
15 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 1.

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
N219130-001ESCITALOPRAMESCITALOPRAM OXALATEEQ 15MG BASECAPSULE / ORALRLD, RS2025-08-29

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N219130-001ESCITALOPRAMEQ 15MG BASECAPSULE / ORALRLD, RS2025-08-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219130-001ESCITALOPRAMEQ 15MG BASECAPSULE / ORALRLD, RS2025-08-2931067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219130-001ESCITALOPRAMEQ 15MG BASECAPSULE / ORALRLD, RS2025-08-29a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
escitalopram
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESCITALOPRAM OXALATE15 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
2725159Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c0401570-a3b0-bef2-7365-c23dc952b8b6Available 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
52427-795-30escitalopram30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52427-795-30EA - Each52427-795a55240d3-61b0-4e29-9bd0-6f0742fe0c9c12025-10-14

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
escitalopramESCITALOPRAMAlmatica Pharma LLCc0401570-a3b0-bef2-7365-c23dc952b8b62025-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 219130
application number: NDA219130
ndc (product): 52427-795

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2725159escitalopram 15 MG Oral CapsulePSNc0401570-a3b0-bef2-7365-c23dc952b8b61
2725159escitalopram 15 MG Oral CapsuleSCDc0401570-a3b0-bef2-7365-c23dc952b8b61
2725159escitalopram (as escitalopram oxalate) 15 MG Oral CapsuleSYc0401570-a3b0-bef2-7365-c23dc952b8b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52427-795-305242707953030 CAPSULE in 1 BOTTLE (52427-795-30) 30 capsule2025-10-06NoNoCurrent