Prescription drug · ANDA
escitalopram NDC 0904-6426
Escitalopram oxalate 10 mg/1 · Tablet, Film coated · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-6426-61 | 0090464266100904642661 | 100 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
N400904642661followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other escitalopram products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4171 | 68788-4171-0168788-4171-0368788-4171-06+2 more |
| Escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0355 | 67046-0355-03 |
| Escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4567 | 70518-4567-00 |
| escitalopram | Escitalopram oxalate 15 mg/1 | CapsuleOral | Almatica Pharma LLC | 52427-795 | 52427-0795-30 |
| Escitalopram | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-865 | 60687-0865-01 |
| escitalopram | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4300 | 70518-4300-0070518-4300-01 |
| escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1465 | 67046-1465-03 |
| escitalopram | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1472 | 67046-1472-03 |
| escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4239 | 70518-4239-0070518-4239-0170518-4239-02+1 more |
| escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8723 | 68788-8723-0168788-8723-0368788-8723-06+2 more |
Other NDCs under ANDA 090939
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6427 |
| escitalopram | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | Torrent Pharmaceuticals Limited | 13668-135 |
| escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Torrent Pharmaceuticals Limited | 13668-136 |
| escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Torrent Pharmaceuticals Limited | 13668-137 |
| escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-6893 |
| escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-7288 |
| escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4171 |
| escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2903 |
| escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2960 |
| escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2240 |
| escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2241 |
| escitalopram | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2242 |
| Escitalopram | Escitalopram oxalate 20 mg/1 | TabletOral | Direct_Rx | 72189-438 |
| escitalopram oxalate | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-761 |
| escitalopram oxalate | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8371 |
| escitalopram oxalate | Escitalopram oxalate 5 mg/1 | TabletOral | Proficient Rx LP | 71205-313 |
| escitalopram oxalate | Escitalopram oxalate 10 mg/1 | TabletOral | Proficient Rx LP | 71205-792 |
| escitalopram oxalate | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0322 |
| escitalopram oxalate | Escitalopram oxalate 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0685 |
| escitalopram oxalate | Escitalopram oxalate 5 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-035 |
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