Escitalopram Oxalate

Product NDC: 31722-569
11-digit product format: 317220569
Labeler code: 31722
Product ID: 31722-569_529ec25b-d886-6690-e063-6394a90a2ad3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Escitalopram Oxalate
Dosage form: SOLUTION
Route: ORAL
Labeler: Camber Pharmaceuticals, Inc.
Application: ANDA202221
Marketing category: ANDA
Marketing start: 2012-06-12
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
31722-569-24	Escitalopram Oxalate	240 mL in 1 BOTTLE	SOLUTION	240		10

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
31722-569-24	ML - Milliliter	31722-569	55a5323e-d357-4799-a011-ff6032537911	1	2013-02-13

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESCITALOPRAM OXALATE	ACTIVE INGREDIENT	5U85DBW7LO	ESCITALOPRAM OXALATE SOLUTION [CAMBER PHARMACEUTICALS, INC.]	1
ESCITALOPRAM	ACTIVE MOIETY	4O4S742ANY	ESCITALOPRAM OXALATE SOLUTION [CAMBER PHARMACEUTICALS, INC.]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	ESCITALOPRAM OXALATE SOLUTION [CAMBER PHARMACEUTICALS, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ESCITALOPRAM OXALATE SOLUTION [CAMBER PHARMACEUTICALS, INC.]	1
MALIC ACID	INACTIVE INGREDIENT	817L1N4CKP	ESCITALOPRAM OXALATE SOLUTION [CAMBER PHARMACEUTICALS, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ESCITALOPRAM OXALATE SOLUTION [CAMBER PHARMACEUTICALS, INC.]	1
PEPPERMINT	INACTIVE INGREDIENT	V95R5KMY2B	ESCITALOPRAM OXALATE SOLUTION [CAMBER PHARMACEUTICALS, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ESCITALOPRAM OXALATE SOLUTION [CAMBER PHARMACEUTICALS, INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ESCITALOPRAM OXALATE SOLUTION [CAMBER PHARMACEUTICALS, INC.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ESCITALOPRAM OXALATE SOLUTION [CAMBER PHARMACEUTICALS, INC.]	1
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	ESCITALOPRAM OXALATE SOLUTION [CAMBER PHARMACEUTICALS, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ESCITALOPRAM OXALATE SOLUTION [CAMBER PHARMACEUTICALS, INC.]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-569	ESCITALOPRAM OXALATE (ESCITALOPRAM OXALATE) SOLUTION [CAMBER PHARMACEUTICALS, INC.]	9	Current NDC, Legacy NDC, 1 package rows	20240606_82d793ee-4039-45fc-ac83-4bd5235f00aa.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	82d793ee-4039-45fc-ac83-4bd5235f00aa	10
351285	escitalopram 1 MG/ML Oral Solution	SCD	82d793ee-4039-45fc-ac83-4bd5235f00aa	10
351285	escitalopram (as escitalopram oxalate) 10 MG per 10 ML Oral Solution	SY	82d793ee-4039-45fc-ac83-4bd5235f00aa	10
351285	escitalopram (as escitalopram oxalate) 5 MG per 5 ML Oral Solution	SY	82d793ee-4039-45fc-ac83-4bd5235f00aa	10

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
31722-569-24	31722056924	240 mL in 1 BOTTLE (31722-569-24)	240 ml	2012-06-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Escitalopram Oxalate	Camber Pharmaceuticals, Inc. \| Hetero Labs Limited Unit III	2026-05-25	HUMAN PRESCRIPTION DRUG LABEL	10