Prescription drug · ANDA

Escitalopram (escitalopram oxalate) NDC 0615-8475

Escitalopram oxalate 5 mg/1 · Tablet, Film coated · Oral · NCS HealthCare of KY, LLC dba Vangard Labs

NDC codes

FDA NDC Directory
Product NDC (as listed)0615-8475Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00615-8475Add 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
0615-8475-050061584750515 TABLET, FILM COATED in 1 BLISTER PACK (0615-8475-05)Marketed from Aug 10, 2023
0615-8475-390061584753930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8475-39)Marketed from May 17, 2023

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 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 090432
Marketing start
Listing expires
Other FDA classes
Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 0615-8475_efdc3d31-555b-443b-bdc7-4729675ab6c1SPL ID efdc3d31-555b-443b-bdc7-4729675ab6c1SPL set ID b29ae169-d60b-464a-9763-f1d8d9e0598dRxCUI 349332, 351249UNII 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

N400615847505 followed by a unit qualifier and the quantity

Package 00615-8475-05. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 090432

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

FDA NDC Directory listings under ANDA 090432
ProductStrengthForm · routeLabelerProduct NDC
Escitalopramescitalopram oxalateEscitalopram oxalate 20 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-311
Escitalopramescitalopram oxalateEscitalopram oxalate 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6023
Escitalopramescitalopram oxalateEscitalopram oxalate 10 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8476
Escitalopramescitalopram oxalateEscitalopram oxalate 5 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-721
Escitalopramescitalopram oxalateEscitalopram oxalate 10 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-722
Escitalopramescitalopram oxalateEscitalopram oxalate 20 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-723
Escitalopramescitalopram oxalateEscitalopram oxalate 20 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-147
Escitalopramescitalopram oxalateEscitalopram oxalate 10 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-374
Escitalopramescitalopram oxalateEscitalopram oxalate 10 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-617
Escitalopramescitalopram oxalateEscitalopram oxalate 20 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8477
Escitalopramescitalopram oxalateEscitalopram oxalate 5 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-373
Escitalopramescitalopram oxalateEscitalopram oxalate 20 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-618
Escitalopramescitalopram oxalateEscitalopram oxalate 20 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-375
Escitalopramescitalopram oxalateEscitalopram oxalate 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6496
Escitalopramescitalopram oxalateEscitalopram oxalate 10 mg/1Tablet, Film coatedOralProficient Rx LP71205-168
Escitalopramescitalopram oxalateEscitalopram oxalate 20 mg/1Tablet, Film coatedOralProficient Rx LP71205-193
Escitalopramescitalopram oxalateEscitalopram oxalate 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-9687
Escitalopramescitalopram oxalateEscitalopram oxalate 10 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0375
Escitalopramescitalopram oxalateEscitalopram oxalate 10 mg/1Tablet, Film coatedOralQPharma, Inc.42708-077
Escitalopramescitalopram oxalateEscitalopram oxalate 20 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-590

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