What is NDC 53746-020?

53746-020 is the product NDC for Escitalopram Oxalate, Escitalopram oxalate 10 mg/1 tablet, film coated, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals of New York LLC, NDC labeler code 53746. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Escitalopram Oxalate NDC 53746-020 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)53746-020Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53746-0020Add 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
53746-020-05	53746002005	500 TABLET, FILM COATED in 1 BOTTLE (53746-020-05)Marketed from May 17, 2017
53746-020-10	53746002010	1000 TABLET, FILM COATED in 1 BOTTLE (53746-020-10)Marketed from May 17, 2017
53746-020-30	53746002030	30 TABLET, FILM COATED in 1 BOTTLE (53746-020-30)Marketed from May 17, 2017
53746-020-90	53746002090	90 TABLET, FILM COATED in 1 BOTTLE (53746-020-90)Marketed from May 17, 2017

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 — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLCNDC labeler code 53746
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205619
Marketing start: May 17, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 53746-020_fe4fad91-a1c2-41f2-933d-94bdfb86d38cSPL ID fe4fad91-a1c2-41f2-933d-94bdfb86d38cSPL set ID 4f941d7a-5abb-4907-a7a1-480245deef87RxCUI 349332, 351249, 351250UNII 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

N453746002005 followed by a unit qualifier and the quantity

Package 53746-0020-05. 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 Oct 15, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Escitalopram tablets are 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. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Escitalopram tablets are 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. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53746-020

What is NDC 53746-020?: 53746-020 is the product NDC for Escitalopram Oxalate, Escitalopram oxalate 10 mg/1 tablet, film coated, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 4 package NDCs, 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?: Amneal Pharmaceuticals of New York LLC, NDC labeler code 53746. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Escitalopram Oxalateescitalopram	Escitalopram oxalate 10 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4703	70518-4703-00
Escitalopram Oxalateescitalopram	Escitalopram oxalate 5 mg/1	TabletOral	Ascent Pharmaceuticals, Inc	43602-473	43602-0473-1043602-0473-30
Escitalopram Oxalateescitalopram	Escitalopram oxalate 10 mg/1	TabletOral	Ascent Pharmaceuticals, Inc	43602-474	43602-0474-1043602-0474-30
Escitalopram Oxalateescitalopram	Escitalopram oxalate 20 mg/1	TabletOral	Ascent Pharmaceuticals, Inc	43602-475	43602-0475-1043602-0475-30
Escitalopram Oxalate	Escitalopram oxalate 20 mg/21	Tablet, Film coatedOral	A-S Medication Solutions	50090-7200	50090-7200-0050090-7200-01
Escitalopram Oxalate	Escitalopram oxalate 20 mg/21	Tablet, Film coatedOral	A-S Medication Solutions	50090-7201	50090-7201-00
Escitalopram Oxalate	Escitalopram oxalate 5 mg/1	Tablet, Film coatedOral	NorthStar RxLLC	72603-149	72603-0149-01
Escitalopram Oxalate	Escitalopram oxalate 10 mg/21	Tablet, Film coatedOral	NorthStar RxLLC	72603-150	72603-0150-01
Escitalopram Oxalate	Escitalopram oxalate 20 mg/21	Tablet, Film coatedOral	NorthStar RxLLC	72603-151	72603-0151-01
escitalopram oxalate	Escitalopram oxalate 5 mg/1	TabletOral	Quallent Pharmaceuticals Health LLC	82009-035	82009-0035-10

All 41 Escitalopram Oxalate NDCs

Other NDCs under ANDA 205619

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

FDA NDC Directory listings under ANDA 205619
Product	Strength	Form · route	Labeler	Product NDC
Escitalopram Oxalate	Escitalopram oxalate 5 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals of New York LLC	53746-019
Escitalopram Oxalate	Escitalopram oxalate 20 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals of New York LLC	53746-021
Escitalopram Oxalate	Escitalopram oxalate 5 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals LLC	65162-019
Escitalopram Oxalate	Escitalopram oxalate 10 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals LLC	65162-020
Escitalopram Oxalate	Escitalopram oxalate 20 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals LLC	65162-021