Prescription drug · ANDA
Citalopram NDC 71610-412
Citalopram hydrobromide 40 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-412-60 | 71610041260 | 90 TABLET in 1 BOTTLE (71610-412-60)Marketed from Mar 30, 2020 |
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
- 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 71610-412_7c318729-6d4b-4a2a-a2fe-155b6513e7d4SPL ID 7c318729-6d4b-4a2a-a2fe-155b6513e7d4SPL set ID 0867140e-a483-4bf7-8326-4a9730cc9d9dRxCUI 309314UNII I1E9D14F36
- 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
N471610041260followed by a unit qualifier and the quantityPackage 71610-0412-60. 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 tablets, USP are indicated for the treatment of depression. The efficacy of citalopram 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 in weight and/o…
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 20 mg/1 | TabletOral | Cipla USA Inc. | 69097-823 |
| 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 | A-S Medication Solutions | 50090-5175 |
| Citalopram | Citalopram hydrobromide 10 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-938 |