NDC codes

FDA NDC Directory
Product NDC (as listed)65862-248Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65862-0248Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
65862-248-2465862024824240 mL in 1 BOTTLE (65862-248-24)Marketed from Apr 3, 2012

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Escitalopram Oxalate
Generic name (nonproprietary)
escitalopram oxalate
Active ingredients
Escitalopram oxalate — 5 mg/5mL
Dosage form
Solution
Route
Oral
Labeler
Aurobindo Pharma LimitedNDC labeler code 65862
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079062
Marketing start
Listing expires
Other FDA classes
Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 65862-248_a8ce07ef-c51d-4af2-bafb-b0a32c090431SPL ID a8ce07ef-c51d-4af2-bafb-b0a32c090431SPL set ID ba60c357-8e61-4a3d-b1dc-25602dbbfc2aRxCUI 351285UNII 5U85DBW7LO
Pharmacologic class
Serotonin Reuptake Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N465862024824 followed by a unit qualifier and the quantity

Package 65862-0248-24. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective . This label includes a boxed warning.

Indications (excerpt from the label)

Escitalopram oral solution is indicated for the treatment of: major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older. generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older. Escitalopram oral solution is a selective serotonin reuptake inhibitor (SSRI) indicated for the: treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older ( 1 ) treatment of generalized anxiety disorder (GAD) in adults and pediatric patients 7 years and older ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65862-248

What is NDC 65862-248?
65862-248 is the product NDC for Escitalopram Oxalate, Escitalopram oxalate 5 mg/5mL solution, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Escitalopram Oxalate.
What is the active ingredient?
Escitalopram oxalate.
Who is the labeler?
Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Escitalopram Oxalate?
40 other product NDCs are listed under this name. See all Escitalopram Oxalate NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Escitalopram Oxalate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Escitalopram OxalateescitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-470370518-4703-00
Escitalopram OxalateescitalopramEscitalopram oxalate 5 mg/1TabletOralAscent Pharmaceuticals, Inc43602-47343602-0473-1043602-0473-30
Escitalopram OxalateescitalopramEscitalopram oxalate 10 mg/1TabletOralAscent Pharmaceuticals, Inc43602-47443602-0474-1043602-0474-30
Escitalopram OxalateescitalopramEscitalopram oxalate 20 mg/1TabletOralAscent Pharmaceuticals, Inc43602-47543602-0475-1043602-0475-30
Escitalopram OxalateEscitalopram oxalate 20 mg/21Tablet, Film coatedOralA-S Medication Solutions50090-720050090-7200-0050090-7200-01
Escitalopram OxalateEscitalopram oxalate 20 mg/21Tablet, Film coatedOralA-S Medication Solutions50090-720150090-7201-00
Escitalopram OxalateEscitalopram oxalate 5 mg/1Tablet, Film coatedOralNorthStar RxLLC72603-14972603-0149-01
Escitalopram OxalateEscitalopram oxalate 10 mg/21Tablet, Film coatedOralNorthStar RxLLC72603-15072603-0150-01
Escitalopram OxalateEscitalopram oxalate 20 mg/21Tablet, Film coatedOralNorthStar RxLLC72603-15172603-0151-01
escitalopram oxalateEscitalopram oxalate 5 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-03582009-0035-10

All 41 Escitalopram Oxalate NDCs

Other NDCs under ANDA 079062

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 079062
ProductStrengthForm · routeLabelerProduct NDC
Escitalopram OxalateEscitalopram oxalate 5 mg/5mLSolutionOralRising Pharma Holdings, Inc.16571-769

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