NDC codes

FDA NDC Directory
Product NDC (as listed)16571-769Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16571-0769Add 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
16571-769-2416571076924240 mL in 1 BOTTLE (16571-769-24)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 oxalate5 mg/5mL
Dosage form
Solution
Route
Oral
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 16571-769_b7140557-3cc1-4c7a-952f-2dca7ae2e9d3SPL ID b7140557-3cc1-4c7a-952f-2dca7ae2e9d3SPL set ID 79fddc2d-2dc2-444f-8fd3-0337090ee744RxCUI 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

N416571076924 followed by a unit qualifier and the quantity

Package 16571-0769-24. 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)

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/5mLSolutionOralAurobindo Pharma Limited65862-248

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