Prescription drug · ANDA

escitalopram oxalate NDC 71205-792

Escitalopram oxalate 10 mg/1 · Tablet · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)71205-792Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0792Add 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
71205-792-30712050792307120507923030 TABLET in 1 BOTTLE (71205-792-30)Marketed from Apr 18, 2023
71205-792-60712050792607120507926060 TABLET in 1 BOTTLE (71205-792-60)Marketed from Apr 18, 2023
71205-792-90712050792907120507929090 TABLET in 1 BOTTLE (71205-792-90)Marketed from Apr 18, 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 — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 71205
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 71205-792_8201a719-7837-45fb-b991-4fcdbf006d24SPL ID 8201a719-7837-45fb-b991-4fcdbf006d24SPL set ID 8201a719-7837-45fb-b991-4fcdbf006d24RxCUI 349332UNII 5U85DBW7LOUPC 0371205792305
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

N471205079230 followed by a unit qualifier and the quantity

Package 71205-0792-30. 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: • Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years ( 1.1 ) • Acute Treatment of Generalized Anxiety Disorder (GAD) in adults ( 1.2 ) 1.1 Major Depressive Disorder Escitalopram tablets are indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [see Clinical Studies ( 14.1 )]. A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and incl…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71205-792

What is NDC 71205-792?
71205-792 is the product NDC for escitalopram oxalate, Escitalopram oxalate 10 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 3 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?
Proficient Rx LP, NDC labeler code 71205. 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 5 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-03582009-0035-10

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/1Tablet, Film coatedOralBryant Ranch Prepack71335-0322
escitalopram oxalateEscitalopram oxalate 20 mg/1TabletOralBryant Ranch Prepack71335-0685
escitalopram oxalateEscitalopram oxalate 5 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-035

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