Prescription drug · ANDA
Escitalopram (Escitalopram oxalate) NDC 59746-281
Escitalopram oxalate 20 mg/1 · Tablet, Film coated · Oral · Jubilant Cadista Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59746-281-01 | 59746028101 | 100 TABLET, FILM COATED in 1 BOTTLE (59746-281-01)Marketed from Jan 1, 2024 | |
| 59746-281-05 | 59746028105 | 500 TABLET, FILM COATED in 1 BOTTLE (59746-281-05)Marketed from Jan 1, 2024 | |
| 59746-281-10 | 59746028110 | 1000 TABLET, FILM COATED in 1 BOTTLE (59746-281-10)Marketed from Jan 1, 2024 | |
| 59746-281-30 | 59746028130 | 30 TABLET, FILM COATED in 1 BOTTLE (59746-281-30)Marketed from Jan 1, 2024 | |
| 59746-281-90 | 59746028190 | 90 TABLET, FILM COATED in 1 BOTTLE (59746-281-90)Marketed from Jan 1, 2024 |
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
- Generic name (nonproprietary)
- escitalopram oxalate
- Active ingredients
- Escitalopram oxalate — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Jubilant Cadista Pharmaceuticals Inc.NDC labeler code 59746
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202280
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 59746-281_a76a9a9c-0066-4250-9f8e-d5ba78529ed4SPL ID a76a9a9c-0066-4250-9f8e-d5ba78529ed4SPL set ID 2db02476-325f-ee47-a7e5-b5aed56c364cRxCUI 349332, 351249, 351250UNII 5U85DBW7LOUPC 0359746280109, 0359746279011
- 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
N459746028101followed by a unit qualifier and the quantityPackage 59746-0281-01. 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 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. Escitalopram tablets are 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 )
Excerpt only. Read the full label for complete information.
About NDC 59746-281
- What is NDC 59746-281?
- 59746-281 is the product NDC for Escitalopram (escitalopram oxalate), Escitalopram oxalate 20 mg/1 tablet, film coated, listed with the FDA by Jubilant Cadista Pharmaceuticals Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Escitalopram (Escitalopram Oxalate).
- What is the active ingredient?
- Escitalopram oxalate.
- Who is the labeler?
- Jubilant Cadista Pharmaceuticals Inc., NDC labeler code 59746. 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 202280
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 |
|---|---|---|---|---|
| Escitalopramescitalopram oxalate | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-279 |
| Escitalopramescitalopram oxalate | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-280 |