Prescription drug · ANDA

Escitalopram NDC 16729-169

Escitalopram oxalate 10 mg/1 · Tablet, Film coated · Oral · Accord Healthcare Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)16729-169Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16729-0169Add 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
16729-169-0116729016901100 TABLET, FILM COATED in 1 BOTTLE (16729-169-01)Marketed from Mar 19, 2013
16729-169-17167290169171000 TABLET, FILM COATED in 1 BOTTLE (16729-169-17)Marketed from Nov 12, 2013

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 202389
Marketing start
Listing expires
Other FDA classes
Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 16729-169_411f7056-e508-9e1b-e063-6294a90a6396SPL ID 411f7056-e508-9e1b-e063-6294a90a6396SPL set ID 84b2028d-eff4-434d-b71e-6a3c0812f625RxCUI 349332, 351249, 351250UNII 5U85DBW7LOUPC 0316729170109, 0316729169103, 0316729168106
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

N416729016901 followed by a unit qualifier and the quantity

Package 16729-0169-01. 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 oxalate 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 ( 1 ) Escitalopram tablet 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202389

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

FDA NDC Directory listings under ANDA 202389
ProductStrengthForm · routeLabelerProduct NDC
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1002
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralProficient Rx LP71205-325
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralProficient Rx LP71205-344
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3069
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1030
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-149
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-236
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-4915
EscitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-766
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-661
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-194
EscitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-168
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-170
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-425
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4985
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-449
EscitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2058

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