Escitalopram

Product NDC: 64725-0251
11-digit product format: 647250251
Labeler code: 64725
Product ID: 64725-0251_2a6665b4-9ccd-4778-913a-e7d805250d0c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Escitalopram
Dosage form: TABLET
Route: ORAL
Labeler: TYA Pharmaceuticals
Application: ANDA078604
Marketing category: ANDA
Marketing start: 2012-09-11
Marketing end: 0000-00-00
Substance: ESCITALOPRAM OXALATE
Active strength: 20 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615	Product name	6	20170718

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64725-0251-1	2020-01-31	C162847	48780-1	9d75b9d0-91ab-f424-e053-dadaa90a57ce	Escitalopram Tablets, USP These highlights do not include all the information needed to use Escitalopram safely and effectively. See full prescribing information for Escitalopram. Escitalopram (Escitalopram) TABLET for ORAL use. Initial U.S. Approval: 2002

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64725-0251-1	Escitalopram	90 in 1 BOTTLE	TABLET	90		4

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64725-0251	ESCITALOPRAM TABLET [TYA PHARMACEUTICALS]	4	Legacy NDC, 1 package rows	20141020_64051fcc-2069-40ad-bf16-f224a435e6f1.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5U85DBW7LO	ESCITALOPRAM OXALATE	219861-08-2	ESCITALOPRAM OXALATE
4O4S742ANY	ESCITALOPRAM	128196-01-0	Escitalopram

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
349332	escitalopram oxalate 10 MG Oral Tablet	PSN	64051fcc-2069-40ad-bf16-f224a435e6f1	4
351250	escitalopram oxalate 20 MG Oral Tablet	PSN	64051fcc-2069-40ad-bf16-f224a435e6f1	4
349332	escitalopram 10 MG Oral Tablet	SCD	64051fcc-2069-40ad-bf16-f224a435e6f1	4
351250	escitalopram 20 MG Oral Tablet	SCD	64051fcc-2069-40ad-bf16-f224a435e6f1	4
349332	escitalopram (as escitalopram oxalate) 10 MG Oral Tablet	SY	64051fcc-2069-40ad-bf16-f224a435e6f1	4
351250	escitalopram (as escitalopram oxalate) 20 MG Oral Tablet	SY	64051fcc-2069-40ad-bf16-f224a435e6f1	4

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
64725-0251-1	64725025101	90 in 1 BOTTLE	Historical