What is NDC 33342-053?

33342-053 is the product NDC for escitalopram, Escitalopram oxalate 5 mg/5mL solution, listed with the FDA by Macleods Pharmaceuticals Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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?

108 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

escitalopram NDC 33342-053 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-053Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0053Add 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 NDC	11-digit (billing)	Package	Copy
33342-053-28	33342005328	240 mL in 1 BOTTLE (33342-053-28)Marketed from Mar 31, 2016

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
Generic name (nonproprietary): escitalopram
Active ingredients: Escitalopram oxalate — 5 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202754
Marketing start: Mar 31, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 33342-053_6dea1a7d-7262-4d3e-9c9e-1db9c8587066SPL ID 6dea1a7d-7262-4d3e-9c9e-1db9c8587066SPL set ID 4d5c3142-b850-49b9-9f5c-81fe15ea7bfbRxCUI 351285UNII 5U85DBW7LOUPC 0333342053282
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

N433342005328 followed by a unit qualifier and the quantity

Package 33342-0053-28. 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 May 24, 2024. 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. 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 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 anxi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-053

What is NDC 33342-053?: 33342-053 is the product NDC for escitalopram, Escitalopram oxalate 5 mg/5mL solution, listed with the FDA by Macleods Pharmaceuticals Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: escitalopram.
What is the active ingredient?: Escitalopram oxalate.
Who is the labeler?: Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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?: 108 other product NDCs are listed under this name. See all escitalopram 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 NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
escitalopram	Escitalopram oxalate 20 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4171	68788-4171-0168788-4171-0368788-4171-06+2 more
Escitalopram	Escitalopram oxalate 10 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0355	67046-0355-03
Escitalopram	Escitalopram oxalate 10 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4567	70518-4567-00
escitalopram	Escitalopram oxalate 15 mg/1	CapsuleOral	Almatica Pharma LLC	52427-795	52427-0795-30
Escitalopram	Escitalopram oxalate 5 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-865	60687-0865-01
escitalopram	Escitalopram oxalate 5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4300	70518-4300-0070518-4300-01
escitalopram	Escitalopram oxalate 20 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1465	67046-1465-03
escitalopram	Escitalopram oxalate 5 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1472	67046-1472-03
escitalopram	Escitalopram oxalate 20 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4239	70518-4239-0070518-4239-0170518-4239-02+1 more
escitalopram	Escitalopram oxalate 20 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8723	68788-8723-0168788-8723-0368788-8723-06+2 more

All 109 escitalopram NDCs