NDC codes

FDA NDC Directory
Product NDC (as listed)0904-6426Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-6426Add 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
0904-6426-610090464266100904642661100 BLISTER PACK in 1 CARTON (0904-6426-61) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Oct 15, 2014

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
Active ingredients
Escitalopram oxalate — 10 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Major PharmaceuticalsNDC labeler code 0904
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 0904-6426_6dd4eb62-4211-41c7-8592-69c0b045b53fSPL ID 6dd4eb62-4211-41c7-8592-69c0b045b53fSPL set ID f4a12048-181e-45ed-a382-f53096d1b689RxCUI 349332, 351250UNII 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

N400904642661 followed by a unit qualifier and the quantity

Package 00904-6426-61. 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 0904-6426

What is NDC 0904-6426?
0904-6426 is the product NDC for escitalopram, Escitalopram oxalate 10 mg/1 tablet, film coated, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
escitalopram.
What is the active ingredient?
Escitalopram oxalate.
Who is the labeler?
Major Pharmaceuticals, NDC labeler code 0904. 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?
108 other product NDCs are listed under this name. See all escitalopram 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
escitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-417168788-4171-0168788-4171-0368788-4171-06+2 more
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralCoupler LLC67046-035567046-0355-03
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-456770518-4567-00
escitalopramEscitalopram oxalate 15 mg/1CapsuleOralAlmatica Pharma LLC52427-79552427-0795-30
EscitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-86560687-0865-01
escitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-430070518-4300-0070518-4300-01
escitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralCoupler LLC67046-146567046-1465-03
escitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralCoupler LLC67046-147267046-1472-03
escitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-423970518-4239-0070518-4239-0170518-4239-02+1 more
escitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-872368788-8723-0168788-8723-0368788-8723-06+2 more

All 109 escitalopram 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 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
escitalopram oxalateEscitalopram oxalate 5 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-035

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