Prescription drug · ANDA
Escitalopram NDC 72189-424
Escitalopram oxalate 10 mg/1 · Tablet, Film coated · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-424-30 | 7218904243072189042430 | 30 TABLET, FILM COATED in 1 BOTTLE (72189-424-30)Marketed from Feb 8, 2023 | |
| 72189-424-90 | 7218904249072189042490 | 90 TABLET, FILM COATED in 1 BOTTLE (72189-424-90)Marketed from Feb 8, 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
- Generic name (nonproprietary)
- escitalopram
- Active ingredients
- Escitalopram oxalate — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Direct_RxNDC labeler code 72189
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078032
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 72189-424_4c4bbd86-4e28-c73d-e063-6294a90a72d6SPL ID 4c4bbd86-4e28-c73d-e063-6294a90a72d6SPL set ID f435d670-87ff-f226-e053-2a95a90ac0eeRxCUI 349332UNII 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
N472189042430followed by a unit qualifier and the quantityPackage 72189-0424-30. 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)
1.1 Major Depressive Disorder Escitalopram is 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 includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or…
Excerpt only. Read the full label for complete information.
About NDC 72189-424
- What is NDC 72189-424?
- 72189-424 is the product NDC for Escitalopram, Escitalopram oxalate 10 mg/1 tablet, film coated, listed with the FDA by Direct_Rx. It has 2 package NDCs, 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?
- Direct_Rx, NDC labeler code 72189. 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 078032
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 10 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-155 |
| Escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-163 |
| Escitalopram | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | SOLCO HEALTHCARE US, LLC | 43547-280 |
| Escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | SOLCO HEALTHCARE US, LLC | 43547-281 |
| Escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | SOLCO HEALTHCARE US, LLC | 43547-282 |
| Escitalopram | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5312 |
| Escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6190 |
| Escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6191 |
| Escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6534 |
| Escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6897 |
| Escitalopram | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-116 |
| Escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-277 |
| Escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-284 |
| Escitalopram | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-865 |
| Escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0355 |
| Escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | RedPharm Drug, Inc. | 67296-1421 |
| Escitalopram | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-591 |
| Escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-592 |
| Escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-593 |
| Escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5248 |
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