Prescription drug · ANDA
escitalopram NDC 55154-7288
Escitalopram oxalate 20 mg/1 · Tablet, Film coated · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-7288-0 | 55154728800 | 10 BLISTER PACK in 1 BAG (55154-7288-0) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Oct 15, 2014 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Cardinal Health 107, LLC
- 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 55154-7288_9f7145c1-6b28-4b3a-8b3c-a3a032864bc8SPL ID 9f7145c1-6b28-4b3a-8b3c-a3a032864bc8SPL set ID cb3f9af4-5bb4-48a8-b972-ff92cff1ea01RxCUI 349332, 351250UNII 5U85DBW7LOUPC 0055154689304
- 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
N455154728800followed by a unit qualifier and the quantityPackage 55154-7288-00. 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.
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 5 mg/1 | Tablet, Film coatedOral | Torrent Pharmaceuticals Limited | 13668-135 |
| escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6427 |
| 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 oxalate | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0322 |
| escitalopram oxalate | Escitalopram oxalate 5 mg/1 | TabletOral | Proficient Rx LP | 71205-313 |
| 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 | 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 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2960 |
| Escitalopram | Escitalopram oxalate 20 mg/1 | TabletOral | Direct_Rx | 72189-438 |
| escitalopram oxalate | Escitalopram oxalate 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0685 |
| escitalopram oxalate | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8371 |
| escitalopram oxalate | Escitalopram oxalate 10 mg/1 | TabletOral | Proficient Rx LP | 71205-792 |
| escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-6893 |
| escitalopram oxalate | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-761 |
| escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4171 |
| escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6426 |
| escitalopram oxalate | Escitalopram oxalate 10 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-036 |
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