Prescription drug · ANDA
Citalopram NDC 69097-823
Citalopram hydrobromide 20 mg/1 · Tablet · Oral · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-823-02 | 69097082302 | 30 TABLET in 1 BOTTLE (69097-823-02)Marketed from Jul 22, 2016 | |
| 69097-823-07 | 69097082307 | 100 TABLET in 1 BOTTLE (69097-823-07)Marketed from Jul 22, 2016 | |
| 69097-823-12 | 69097082312 | 500 TABLET in 1 BOTTLE (69097-823-12)Marketed from Jul 22, 2016 | |
| 69097-823-15 | 69097082315 | 1000 TABLET in 1 BOTTLE (69097-823-15)Marketed from Jul 22, 2016 |
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 — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Cipla USA Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077534
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 69097-823_6f82cb3c-dec1-4200-9cfa-9b41438a71b8SPL ID 6f82cb3c-dec1-4200-9cfa-9b41438a71b8SPL set ID 0580559a-783a-4a0a-8d81-ee30a29077c5RxCUI 200371, 283672, 309314UNII I1E9D14F36UPC 0369097822071, 0369097823122, 0369097824075, 0369097823078
- 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
N469097082302followed by a unit qualifier and the quantityPackage 69097-0823-02. 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 is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14 )] . Citalopram is 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 077534
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 Hydrobromidecitalopram | Citalopram hydrobromide 40 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-208 |
| Citalopram | Citalopram hydrobromide 40 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2228 |
| Citalopram Hydrobromidecitalopram | Citalopram hydrobromide 20 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-092 |
| Citalopram Hydrobromidecitalopram | Citalopram hydrobromide 40 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-112 |
| Citalopram | Citalopram hydrobromide 10 mg/1 | TabletOral | Cipla USA Inc. | 69097-822 |
| Citalopram | Citalopram hydrobromide 40 mg/1 | TabletOral | Cipla USA Inc. | 69097-824 |
| Citalopram | Citalopram hydrobromide 20 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-137 |
| Citalopram | Citalopram hydrobromide 40 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-209 |
| Citalopram Hydrobromidecitalopram | Citalopram hydrobromide 10 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-628 |
| Citalopram Hydrobromidecitalopram | Citalopram hydrobromide 20 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-629 |
| Citalopram | Citalopram hydrobromide 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2617 |
| Citalopram | Citalopram hydrobromide 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-5172 |
| Citalopram | Citalopram hydrobromide 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-5170 |
| Citalopram | Citalopram hydrobromide 40 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-412 |
| Citalopram | Citalopram hydrobromide 40 mg/1 | TabletOral | A-S Medication Solutions | 50090-5175 |
| Citalopram | Citalopram hydrobromide 10 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-938 |