Prescription drug · ANDA

Escitalopram Oxalate NDC 33342-036

Escitalopram oxalate 5 mg/1 · Tablet, Film coated · Oral · Macleods Pharmaceuticals Limited

NDC codes

FDA NDC Directory
Product NDC (as listed)33342-036Labeler and product segments. Claims need a package NDC.
Product NDC at billing width33342-0036Add 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
33342-036-1133342003611100 TABLET, FILM COATED in 1 BOTTLE (33342-036-11)Marketed from Sep 11, 2012
33342-036-1233342003612100 TABLET, FILM COATED in 1 CARTON (33342-036-12)Marketed from Sep 11, 2012
33342-036-1533342003615500 TABLET, FILM COATED in 1 BOTTLE (33342-036-15)Marketed from Sep 9, 2015

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/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202210
Marketing start
Listing expires
Other FDA classes
Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 33342-036_53210109-53db-4d08-8ea4-be60e5597cafSPL ID 53210109-53db-4d08-8ea4-be60e5597cafSPL set ID 24b43cb4-1a26-44a2-b1d8-a40239eb5c7cRxCUI 349332, 351249, 351250UNII 5U85DBW7LOUPC 0333342036155, 0333342037152, 0333342037114, 0333342038159, 0333342038111, 0333342036117
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

N433342003611 followed by a unit qualifier and the quantity

Package 33342-0036-11. 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 tablets 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. Additional pediatric use information is approved for AbbVie Inc.’s LEXAPRO (escitalopram) tablets and LEXAPRO (escitalopram) oral solution. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Escitalopram tablets 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202210

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

FDA NDC Directory listings under ANDA 202210
ProductStrengthForm · routeLabelerProduct NDC
Escitalopram OxalateEscitalopram oxalate 10 mg/21Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-037
Escitalopram OxalateEscitalopram oxalate 20 mg/21Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-038
Escitalopram OxalateEscitalopram oxalate 20 mg/21Tablet, Film coatedOralA-S Medication Solutions50090-7200
Escitalopram OxalateEscitalopram oxalate 20 mg/21Tablet, Film coatedOralA-S Medication Solutions50090-7201
Escitalopram OxalateEscitalopram oxalate 10 mg/21Tablet, Film coatedOralNorthStar RxLLC72603-150
Escitalopram OxalateEscitalopram oxalate 5 mg/1Tablet, Film coatedOralNorthStar RxLLC72603-149
Escitalopram OxalateEscitalopram oxalate 20 mg/21Tablet, Film coatedOralNorthStar RxLLC72603-151

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Escitalopram Oxalate NDC 33342-036 | Med-Code