Escitalopram

Product NDC: 64725-0250
11-digit product format: 647250250
Labeler code: 64725
Product ID: 64725-0250_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: 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
64725-0250-1	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
64725-0250-1	Escitalopram	90 in 1 BOTTLE	TABLET	90		4

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESCITALOPRAM OXALATE	ACTIVE INGREDIENT	5U85DBW7LO	ESCITALOPRAM TABLET [TYA PHARMACEUTICALS]	4
ESCITALOPRAM	ACTIVE MOIETY	4O4S742ANY	ESCITALOPRAM TABLET [TYA PHARMACEUTICALS]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ESCITALOPRAM TABLET [TYA PHARMACEUTICALS]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ESCITALOPRAM TABLET [TYA PHARMACEUTICALS]	4
HYPROMELLOSE 2208 (3 MPA.S)	INACTIVE INGREDIENT	9H4L916OBU	ESCITALOPRAM TABLET [TYA PHARMACEUTICALS]	4
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	ESCITALOPRAM TABLET [TYA PHARMACEUTICALS]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ESCITALOPRAM TABLET [TYA PHARMACEUTICALS]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ESCITALOPRAM TABLET [TYA PHARMACEUTICALS]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ESCITALOPRAM TABLET [TYA PHARMACEUTICALS]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ESCITALOPRAM TABLET [TYA PHARMACEUTICALS]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ESCITALOPRAM TABLET [TYA PHARMACEUTICALS]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ESCITALOPRAM TABLET [TYA PHARMACEUTICALS]	4

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64725-0250	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
64725-0250-1	64725025001	90 in 1 BOTTLE	Historical