Prescription drug · ANDA

Escitalopram Oxalate (Escitalopram) NDC 69097-847

Escitalopram oxalate 5 mg/1 · Tablet, Film coated · Oral · Cipla USA Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)69097-847Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69097-0847Add 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
69097-847-02690970847026909708470230 TABLET, FILM COATED in 1 BOTTLE (69097-847-02)Marketed from Jun 16, 2016
69097-847-05690970847056909708470590 TABLET, FILM COATED in 1 BOTTLE (69097-847-05)Marketed from Jun 16, 2016
69097-847-076909708470769097084707100 TABLET, FILM COATED in 1 BOTTLE (69097-847-07)Marketed from Jun 16, 2016
69097-847-126909708471269097084712500 TABLET, FILM COATED in 1 BOTTLE (69097-847-12)Marketed from Jun 16, 2016
69097-847-1569097084715690970847151000 TABLET, FILM COATED in 1 BOTTLE (69097-847-15)Marketed from Jun 16, 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 Oxalate
Generic name (nonproprietary)
escitalopram
Active ingredients
Escitalopram oxalate — 5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Cipla USA Inc.NDC labeler code 69097
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078604
Marketing start
Listing expires
Other FDA classes
Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 69097-847_7e44336f-9692-42ff-af45-f98edd0c803cSPL ID 7e44336f-9692-42ff-af45-f98edd0c803cSPL set ID 31ce0b82-58fe-44f3-8887-c55d8df1b773RxCUI 349332, 351249, 351250UNII 5U85DBW7LOUPC 0369097847050, 0369097848057
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

N469097084702 followed by a unit qualifier and the quantity

Package 69097-0847-02. 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, USP 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 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)

About NDC 69097-847

What is NDC 69097-847?
69097-847 is the product NDC for Escitalopram Oxalate (escitalopram), Escitalopram oxalate 5 mg/1 tablet, film coated, listed with the FDA by Cipla USA Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Escitalopram Oxalate (Escitalopram).
What is the active ingredient?
Escitalopram oxalate.
Who is the labeler?
Cipla USA Inc., NDC labeler code 69097. 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 078604

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

FDA NDC Directory listings under ANDA 078604
ProductStrengthForm · routeLabelerProduct NDC
Escitalopram oxalateescitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC53401-037
Escitalopram OxalateescitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralLegacy Pharmaceutical Packaging, LLC68645-519
Escitalopram OxalateescitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralLegacy Pharmaceutical Packaging, LLC68645-520
Escitalopram OxalateescitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralCipla USA Inc.69097-848
Escitalopram OxalateescitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralCipla USA Inc.69097-849
Escitalopram OxalateescitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4703
Escitalopram oxalateescitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-534
Escitalopram oxalateescitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralExelan Pharmaceuticals Inc.76282-249
Escitalopram oxalateescitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralExelan Pharmaceuticals Inc.76282-250
Escitalopram oxalateescitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralExelan Pharmaceuticals Inc.76282-251

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