Prescription drug · ANDA
Citalopram NDC 62135-540
Citalopram hydrobromide 10 mg/5mL · Solution · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-540-24 | 62135054024 | 2 TRAY in 1 BOX (62135-540-24) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-540-10)Marketed from Apr 3, 2025 | |
| 62135-540-47 | 62135054047 | 473 mL in 1 BOTTLE (62135-540-47)Marketed from Oct 31, 2022 |
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)
- Citalopram
- Generic name (nonproprietary)
- citalopram
- Active ingredients
- Citalopram hydrobromide — 10 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077629
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 62135-540_4a2ccdf3-3193-9182-e063-6294a90ad893SPL ID 4a2ccdf3-3193-9182-e063-6294a90ad893SPL set ID b1f0c6e8-85eb-4368-8709-9cace32415cbRxCUI 309313UNII I1E9D14F36UPC 0362135540470
- 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
N462135054024followed by a unit qualifier and the quantityPackage 62135-0540-24. 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)
INDICATIONS AND USAGE Citalopram Oral Solution is indicated for the treatment of depression. The efficacy of Citalopram Oral Solution in the treatment of depression was established in 4 to 6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder ( see CLINICAL PHARMACOLOGY ). 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 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077629
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 |
|---|---|---|---|---|
| Citalopram | Citalopram hydrobromide 10 mg/5mL | SolutionOral | Chartwell Governmental & Specialty RX, LLC. | 68999-540 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.