Prescription drug · ANDA
Citalopram NDC 65162-054
Citalopram hydrobromide 40 mg/1 · Tablet · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-054-03 | 65162005403 | 30 TABLET in 1 BOTTLE (65162-054-03)Marketed from Apr 6, 2010 | |
| 65162-054-10 | 65162005410 | 100 TABLET in 1 BOTTLE (65162-054-10)Marketed from Apr 6, 2010 | |
| 65162-054-11 | 65162005411 | 1000 TABLET in 1 BOTTLE (65162-054-11)Marketed from Apr 6, 2010 | |
| 65162-054-50 | 65162005450 | 500 TABLET in 1 BOTTLE (65162-054-50)Marketed from Apr 6, 2010 |
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 — 40 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077289
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 65162-054_a42ab6f8-0664-4d9d-9da0-116bba7e55fcSPL ID a42ab6f8-0664-4d9d-9da0-116bba7e55fcSPL set ID 6a402640-1c9d-4fca-8b5b-e1ac1dd4ca5aRxCUI 200371, 283672, 309314UNII I1E9D14F36UPC 0365162053500, 0365162054507, 0365162052503
- 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
N465162005403followed by a unit qualifier and the quantityPackage 65162-0054-03. 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)
Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14) ]. Citalopram tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077289
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 20 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-063 |
| Citalopram | Citalopram hydrobromide 10 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-052 |
| Citalopram | Citalopram hydrobromide 20 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-053 |
- openFDA data updated
Med-Code stores this record for up to 24 hours before requesting it again.
Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.