Prescription drug · ANDA
Escitalopram Oral Solution (Escitalopram oral) NDC 62135-729
Escitalopram oxalate 5 mg/5mL · Solution · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-729-24 | 62135072924 | 2 TRAY in 1 BOX (62135-729-24) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-729-10)Marketed from Feb 26, 2025 | |
| 62135-729-37 | 62135072937 | 240 mL in 1 BOTTLE (62135-729-37)Marketed from Aug 11, 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 Oral Solution
- Generic name (nonproprietary)
- escitalopram oral
- Active ingredients
- Escitalopram oxalate — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Chartwell RX, LLCNDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090477
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 62135-729_2f987c95-695b-d900-e063-6294a90a0cf8SPL ID 2f987c95-695b-d900-e063-6294a90a0cf8SPL set ID 0458445b-e431-4c82-86b8-90373813c10aRxCUI 351285UNII 5U85DBW7LOUPC 0362135729370
- 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
N462135072924followed by a unit qualifier and the quantityPackage 62135-0729-24. 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 and LEXAPRO (escitalopram) oral solution. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. 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 )…
Excerpt only. Read the full label for complete information.
About NDC 62135-729
- What is NDC 62135-729?
- 62135-729 is the product NDC for Escitalopram Oral Solution (escitalopram oral), Escitalopram oxalate 5 mg/5mL solution, listed with the FDA by Chartwell RX, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Escitalopram Oral Solution (Escitalopram Oral).
- What is the active ingredient?
- Escitalopram oxalate.
- Who is the labeler?
- Chartwell RX, LLC, NDC labeler code 62135. 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 Oral Solution?
- 1 other product NDC are listed under this name. See all Escitalopram Oral Solution NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Escitalopram Oral Solution 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 Oral Solutionescitalopram oral | Escitalopram oxalate 5 mg/5mL | SolutionOral | Chartwell Governmental & Specialty RX, LLC. | 68999-729 | 68999-0729-24 |
Other NDCs under ANDA 090477
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 Oral Solutionescitalopram oral | Escitalopram oxalate 5 mg/5mL | SolutionOral | Chartwell Governmental & Specialty RX, LLC. | 68999-729 |