Prescription drug · ANDA
Citalopram Hydrobromide (citalopram) NDC 76282-629
Citalopram hydrobromide 20 mg/1 · Tablet · Oral · Exelan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76282-629-05 | 76282062905 | 500 TABLET in 1 BOTTLE (76282-629-05)Marketed from Nov 10, 2017 | |
| 76282-629-10 | 76282062910 | 1000 TABLET in 1 BOTTLE (76282-629-10)Marketed from Nov 10, 2017 | |
| 76282-629-30 | 76282062930 | 30 TABLET in 1 BOTTLE (76282-629-30)Marketed from Nov 10, 2017 | |
| 76282-629-90 | 76282062990 | 90 TABLET in 1 BOTTLE (76282-629-90)Marketed from Nov 10, 2017 |
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 Hydrobromide
- Generic name (nonproprietary)
- citalopram
- Active ingredients
- Citalopram hydrobromide — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Exelan Pharmaceuticals 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 76282-629_fd69f24e-8108-4b9e-92ca-13ebbdf86e45SPL ID fd69f24e-8108-4b9e-92ca-13ebbdf86e45SPL set ID a8e8fde2-8392-4d5b-902b-e2b9dd55a02dRxCUI 200371, 283672, 309314UNII I1E9D14F36UPC 0376282208909, 0376282629902, 0376282628905
- 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
N476282062905followed by a unit qualifier and the quantityPackage 76282-0629-05. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 | 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 |