Escitalopram

Product NDC: 53217-167
11-digit product format: 532170167
Labeler code: 53217
Product ID: 53217-167_4886349c-74c3-4fb0-a717-2296020cafe9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Escitalopram
Dosage form: TABLET
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA078604
Marketing category: ANDA
Marketing start: 2012-09-11
Marketing end: 0000-00-00
Substance: ESCITALOPRAM OXALATE
Active strength: 10 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2018-12-31
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
53217-167-30	2020-01-31	C162847	48780-1	9d75b9d1-0558-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
53217-167-55	2020-01-31	C162847	48780-1	9d75b9d1-0558-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
53217-167-60	2020-01-31	C162847	48780-1	9d75b9d1-0558-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
53217-167-90	2020-01-31	C162847	48780-1	9d75b9d1-0558-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	SPL version
53217-167-30	Escitalopram	30 in 1 BOTTLE	TABLET	30	1
53217-167-55	Escitalopram	500 in 1 BOTTLE	TABLET	500	1
53217-167-60	Escitalopram	60 in 1 BOTTLE	TABLET	60	1
53217-167-90	Escitalopram	90 in 1 BOTTLE	TABLET	90	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-167	ESCITALOPRAM TABLET [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 4 package rows	20170223_dbd3fe4f-75c9-4d1c-85c3-5466ca785283.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	dbd3fe4f-75c9-4d1c-85c3-5466ca785283	1
349332	escitalopram 10 MG Oral Tablet	SCD	dbd3fe4f-75c9-4d1c-85c3-5466ca785283	1
349332	escitalopram (as escitalopram oxalate) 10 MG Oral Tablet	SY	dbd3fe4f-75c9-4d1c-85c3-5466ca785283	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53217-167-30	53217016730	30 in 1 BOTTLE	Historical
53217-167-55	53217016755	500 in 1 BOTTLE	Historical
53217-167-60	53217016760	60 in 1 BOTTLE	Historical
53217-167-90	53217016790	90 in 1 BOTTLE	Historical