Prescription drug · ANDA

Escitalopram NDC 43547-281

Escitalopram oxalate 10 mg/1 · Tablet, Film coated · Oral · SOLCO HEALTHCARE US, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)43547-281Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43547-0281Add 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
43547-281-1043547028110100 TABLET, FILM COATED in 1 BOTTLE (43547-281-10)Marketed from Feb 1, 2016
43547-281-11435470281111000 TABLET, FILM COATED in 1 BOTTLE (43547-281-11)Marketed from Feb 1, 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 — 10 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078032
Marketing start
Listing expires
Other FDA classes
Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 43547-281_9eb8b7e7-53d7-461e-86e5-670262dad840SPL ID 9eb8b7e7-53d7-461e-86e5-670262dad840SPL set ID 155e973a-f4ff-4e5a-b937-09f1e106fe39RxCUI 349332, 351249, 351250UNII 5U85DBW7LOUPC 0343547281106, 0343547280109, 0343547282103
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

N443547028110 followed by a unit qualifier and the quantity

Package 43547-0281-10. 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 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 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 078032

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

FDA NDC Directory listings under ANDA 078032
ProductStrengthForm · routeLabelerProduct NDC
EscitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5312
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralDirect_Rx72189-424
EscitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-865
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralCoupler LLC67046-0355
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralDirect_Rx72189-451
EscitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralDirect_Rx72189-449
EscitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-116
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2317
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals, Inc.68788-7461
EscitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-591
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-592
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-5248
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-593
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4567
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2472
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-282
EscitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-280
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6534
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0320
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-277

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