FDA.reportPublic FDA data

escitalopram

Product NDC
16571-756
11-digit product format
165710756
Labeler code
16571
Product ID
16571-756_9929f3a5-d78b-4d99-bf87-d2693a9ac47e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA078777
Marketing category
ANDA
Marketing start
2023-06-10
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

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 Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui349332, 351249, 351250

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
16571-756-01escitalopram100 in 1 BOTTLETABLET, FILM COATED1002
16571-756-10escitalopram1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-756-01EA - Each16571-7565e6945e7-94d5-46b4-af20-39805fddc94e12023-07-06
16571-756-10EA - Each16571-756e0e0e795-698a-4f9e-a904-d334cbb2f24412023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-756ESCITALOPRAM TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]2Current NDC, 2 package rows20241114_ccbe97b5-da68-4fff-929a-240dd705fe6f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN76a8aedd-7853-4d3f-9a00-f8222f55bea88
349332escitalopram 10 MG Oral TabletSCD76a8aedd-7853-4d3f-9a00-f8222f55bea88
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY76a8aedd-7853-4d3f-9a00-f8222f55bea88
349332escitalopram oxalate 10 MG Oral TabletPSN1b2ec266-be5b-9265-e063-6294a90a10e33
349332escitalopram oxalate 10 MG Oral TabletPSNd16a7510-c787-4c9b-818b-1ffbcc62b3c33
349332escitalopram 10 MG Oral TabletSCD1b2ec266-be5b-9265-e063-6294a90a10e33
349332escitalopram 10 MG Oral TabletSCDd16a7510-c787-4c9b-818b-1ffbcc62b3c33
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY1b2ec266-be5b-9265-e063-6294a90a10e33
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYd16a7510-c787-4c9b-818b-1ffbcc62b3c33
349332escitalopram oxalate 10 MG Oral TabletPSNccbe97b5-da68-4fff-929a-240dd705fe6f2
351250escitalopram oxalate 20 MG Oral TabletPSNccbe97b5-da68-4fff-929a-240dd705fe6f2
351249escitalopram oxalate 5 MG Oral TabletPSNccbe97b5-da68-4fff-929a-240dd705fe6f2
349332escitalopram 10 MG Oral TabletSCDccbe97b5-da68-4fff-929a-240dd705fe6f2
351250escitalopram 20 MG Oral TabletSCDccbe97b5-da68-4fff-929a-240dd705fe6f2
351249escitalopram 5 MG Oral TabletSCDccbe97b5-da68-4fff-929a-240dd705fe6f2
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYccbe97b5-da68-4fff-929a-240dd705fe6f2
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYccbe97b5-da68-4fff-929a-240dd705fe6f2
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSYccbe97b5-da68-4fff-929a-240dd705fe6f2
349332escitalopram oxalate 10 MG Oral TabletPSN64de12e0-c35f-4082-b902-ddbaee8158a61
349332escitalopram oxalate 10 MG Oral TabletPSN2876fd8f-15da-bfe4-e063-6394a90a7f561
349332escitalopram 10 MG Oral TabletSCD64de12e0-c35f-4082-b902-ddbaee8158a61
349332escitalopram 10 MG Oral TabletSCD2876fd8f-15da-bfe4-e063-6394a90a7f561
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY64de12e0-c35f-4082-b902-ddbaee8158a61
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY2876fd8f-15da-bfe4-e063-6394a90a7f561

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
16571-756-0116571075601100 TABLET, FILM COATED in 1 BOTTLE (16571-756-01) 2023-06-10NoNoHistorical
16571-756-10165710756101000 TABLET, FILM COATED in 1 BOTTLE (16571-756-10) 2023-06-10NoNoHistorical