Escitalopram

Product NDC: 64205-585
11-digit product format: 642050585
Labeler code: 64205
Product ID: 64205-585_9c5798fc-0e62-4967-888c-4db58c9ab86c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Escitalopram
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: ReadyMeds
Application: ANDA076765
Marketing category: ANDA
Marketing start: 2012-03-14
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: 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
64205-585-30	2019-11-27	C162847	48780-1	9855e2a2-3867-60a7-e053-dbdaa90a05bd	These highlights do not include all the information needed to use Escitalopram Tablets USP safely and effectively. See full prescribing information for Escitalopram Tablets USP. Initial U.S. Approval: 2002
64205-585-90	2019-11-27	C162847	48780-1	9855e2a2-3867-60a7-e053-dbdaa90a05bd	These highlights do not include all the information needed to use Escitalopram Tablets USP safely and effectively. See full prescribing information for Escitalopram Tablets USP. Initial U.S. Approval: 2002

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64205-585-30	Escitalopram	30 in 1 BOTTLE	TABLET, FILM COATED	30		5
64205-585-90	Escitalopram	90 in 1 BOTTLE	TABLET, FILM COATED	90		5

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESCITALOPRAM OXALATE	ACTIVE INGREDIENT	5U85DBW7LO	ESCITALOPRAM TABLET, FILM COATED [READYMEDS]	5
ESCITALOPRAM	ACTIVE MOIETY	4O4S742ANY	ESCITALOPRAM TABLET, FILM COATED [READYMEDS]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ESCITALOPRAM TABLET, FILM COATED [READYMEDS]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ESCITALOPRAM TABLET, FILM COATED [READYMEDS]	5
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	ESCITALOPRAM TABLET, FILM COATED [READYMEDS]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ESCITALOPRAM TABLET, FILM COATED [READYMEDS]	5
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ESCITALOPRAM TABLET, FILM COATED [READYMEDS]	5
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	ESCITALOPRAM TABLET, FILM COATED [READYMEDS]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ESCITALOPRAM TABLET, FILM COATED [READYMEDS]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ESCITALOPRAM TABLET, FILM COATED [READYMEDS]	5

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64205-585	ESCITALOPRAM TABLET, FILM COATED [READYMEDS]	5	Legacy NDC, 2 package rows	20140505_c9474ebb-15a0-4cdc-b025-5b4e800151d3.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	c9474ebb-15a0-4cdc-b025-5b4e800151d3	5
349332	escitalopram 10 MG Oral Tablet	SCD	c9474ebb-15a0-4cdc-b025-5b4e800151d3	5
349332	escitalopram (as escitalopram oxalate) 10 MG Oral Tablet	SY	c9474ebb-15a0-4cdc-b025-5b4e800151d3	5

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
64205-585-30	64205058530	30 in 1 BOTTLE	Historical
64205-585-90	64205058590	90 in 1 BOTTLE	Historical