Prescription drug · ANDA

escitalopram oxalate NDC 82009-035

Escitalopram oxalate 5 mg/1 · Tablet · Oral · Quallent Pharmaceuticals Health LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)82009-035Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82009-0035Add 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
82009-035-1082009003510820090035101000 TABLET in 1 BOTTLE (82009-035-10)Marketed from Mar 1, 2023

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 — 5 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Quallent Pharmaceuticals Health LLCNDC labeler code 82009
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090939
Marketing start
Listing expires
Other FDA classes
Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 82009-035_8535cead-aff5-4a22-b788-1d5926e02097SPL ID 8535cead-aff5-4a22-b788-1d5926e02097SPL set ID d8e22060-4d06-42bf-a881-caaf65ecc3e3RxCUI 349332, 351249, 351250UNII 5U85DBW7LOUPC 0382009036106
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

N482009003510 followed by a unit qualifier and the quantity

Package 82009-0035-10. 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 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 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.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 82009-035

What is NDC 82009-035?
82009-035 is the product NDC for escitalopram oxalate, Escitalopram oxalate 5 mg/1 tablet, listed with the FDA by Quallent Pharmaceuticals Health LLC. It has 1 package NDC, 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?
Quallent Pharmaceuticals Health LLC, NDC labeler code 82009. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Escitalopram OxalateescitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-470370518-4703-00
Escitalopram OxalateescitalopramEscitalopram oxalate 5 mg/1TabletOralAscent Pharmaceuticals, Inc43602-47343602-0473-1043602-0473-30
Escitalopram OxalateescitalopramEscitalopram oxalate 10 mg/1TabletOralAscent Pharmaceuticals, Inc43602-47443602-0474-1043602-0474-30
Escitalopram OxalateescitalopramEscitalopram oxalate 20 mg/1TabletOralAscent Pharmaceuticals, Inc43602-47543602-0475-1043602-0475-30
Escitalopram OxalateEscitalopram oxalate 20 mg/21Tablet, Film coatedOralA-S Medication Solutions50090-720050090-7200-0050090-7200-01
Escitalopram OxalateEscitalopram oxalate 20 mg/21Tablet, Film coatedOralA-S Medication Solutions50090-720150090-7201-00
Escitalopram OxalateEscitalopram oxalate 5 mg/1Tablet, Film coatedOralNorthStar RxLLC72603-14972603-0149-01
Escitalopram OxalateEscitalopram oxalate 10 mg/21Tablet, Film coatedOralNorthStar RxLLC72603-15072603-0150-01
Escitalopram OxalateEscitalopram oxalate 20 mg/21Tablet, Film coatedOralNorthStar RxLLC72603-15172603-0151-01
escitalopram oxalateEscitalopram oxalate 10 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-03682009-0036-10

All 41 escitalopram oxalate NDCs

Other NDCs under ANDA 090939

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

FDA NDC Directory listings under ANDA 090939
ProductStrengthForm · routeLabelerProduct NDC
escitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6426
escitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6427
escitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralTorrent Pharmaceuticals Limited13668-135
escitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralTorrent Pharmaceuticals Limited13668-136
escitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralTorrent Pharmaceuticals Limited13668-137
escitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-6893
escitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-7288
escitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-4171
escitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2903
escitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2960
escitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2240
escitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2241
escitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2242
EscitalopramEscitalopram oxalate 20 mg/1TabletOralDirect_Rx72189-438
escitalopram oxalateEscitalopram oxalate 10 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-761
escitalopram oxalateEscitalopram oxalate 10 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8371
escitalopram oxalateEscitalopram oxalate 5 mg/1TabletOralProficient Rx LP71205-313
escitalopram oxalateEscitalopram oxalate 10 mg/1TabletOralProficient Rx LP71205-792
escitalopram oxalateEscitalopram oxalate 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0322
escitalopram oxalateEscitalopram oxalate 20 mg/1TabletOralBryant Ranch Prepack71335-0685

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