Escitalopram Oxalate

Product NDC: 65862-248
11-digit product format: 658620248
Labeler code: 65862
Product ID: 65862-248_a8ce07ef-c51d-4af2-bafb-b0a32c090431
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Escitalopram Oxalate
Dosage form: SOLUTION
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA079062
Marketing category: ANDA
Marketing start: 2012-04-03
Substance: ESCITALOPRAM OXALATE
Active strength: 5 mg/5mL
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
ESCITALOPRAM OXALATE	5 mg/5mL

Field, Values table
Field	Values
Unii	5U85DBW7LO
Rxcui	351285

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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65862-248-24	Escitalopram Oxalate	240 mL in 1 BOTTLE	SOLUTION	240		20

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-248-24	ML - Milliliter	65862-248	393a7f33-93a6-4662-829b-4fb83ace9f84	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESCITALOPRAM OXALATE	ACTIVE INGREDIENT	5U85DBW7LO	ESCITALOPRAM OXALATE SOLUTION [AUROBINDO PHARMA LIMITED]	4
ESCITALOPRAM	ACTIVE MOIETY	4O4S742ANY	ESCITALOPRAM OXALATE SOLUTION [AUROBINDO PHARMA LIMITED]	4
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	ESCITALOPRAM OXALATE SOLUTION [AUROBINDO PHARMA LIMITED]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ESCITALOPRAM OXALATE SOLUTION [AUROBINDO PHARMA LIMITED]	4
MALIC ACID	INACTIVE INGREDIENT	817L1N4CKP	ESCITALOPRAM OXALATE SOLUTION [AUROBINDO PHARMA LIMITED]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ESCITALOPRAM OXALATE SOLUTION [AUROBINDO PHARMA LIMITED]	4
PEPPERMINT	INACTIVE INGREDIENT	V95R5KMY2B	ESCITALOPRAM OXALATE SOLUTION [AUROBINDO PHARMA LIMITED]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ESCITALOPRAM OXALATE SOLUTION [AUROBINDO PHARMA LIMITED]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ESCITALOPRAM OXALATE SOLUTION [AUROBINDO PHARMA LIMITED]	4
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ESCITALOPRAM OXALATE SOLUTION [AUROBINDO PHARMA LIMITED]	4
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	ESCITALOPRAM OXALATE SOLUTION [AUROBINDO PHARMA LIMITED]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	ESCITALOPRAM OXALATE SOLUTION [AUROBINDO PHARMA LIMITED]	4

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-248	ESCITALOPRAM OXALATE SOLUTION [AUROBINDO PHARMA LIMITED]	19	Current NDC, Legacy NDC, 1 package rows	20240521_ba60c357-8e61-4a3d-b1dc-25602dbbfc2a.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5U85DBW7LO	ESCITALOPRAM OXALATE	219861-08-2	ESCITALOPRAM OXALATE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
351285	escitalopram 5 MG in 5 mL Oral Solution	PSN	ba60c357-8e61-4a3d-b1dc-25602dbbfc2a	20
351285	escitalopram 1 MG/ML Oral Solution	SCD	ba60c357-8e61-4a3d-b1dc-25602dbbfc2a	20
351285	escitalopram (as escitalopram oxalate) 10 MG per 10 ML Oral Solution	SY	ba60c357-8e61-4a3d-b1dc-25602dbbfc2a	20
351285	escitalopram (as escitalopram oxalate) 5 MG per 5 ML Oral Solution	SY	ba60c357-8e61-4a3d-b1dc-25602dbbfc2a	20

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-248-24	65862024824	240 mL in 1 BOTTLE (65862-248-24)	240 ml	2012-04-03	0000-00-00	No	No	Current