Prescription drug · ANDA
Citalopram Hydrobromide NDC 63187-220
Citalopram hydrobromide 10 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-220-00 | 63187022000 | 100 TABLET in 1 BOTTLE (63187-220-00)Marketed from Nov 2, 2015 | |
| 63187-220-30 | 63187022030 | 30 TABLET in 1 BOTTLE (63187-220-30)Marketed from Nov 2, 2015 | |
| 63187-220-60 | 63187022060 | 60 TABLET in 1 BOTTLE (63187-220-60)Marketed from Nov 2, 2015 | |
| 63187-220-72 | 63187022072 | 120 TABLET in 1 BOTTLE (63187-220-72)Marketed from Nov 2, 2015 | |
| 63187-220-90 | 63187022090 | 90 TABLET in 1 BOTTLE (63187-220-90)Marketed from Nov 2, 2015 |
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 hydrobromide
- Active ingredients
- Citalopram hydrobromide — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078216
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 63187-220_70196c8d-c1c0-457c-b9b2-dd1182416714SPL ID 70196c8d-c1c0-457c-b9b2-dd1182416714SPL set ID 1a136cc3-d655-4f3c-8710-2603dc008492RxCUI 200371, 283672UNII I1E9D14F36UPC 0363187220303, 0363187203900
- 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
N463187022000followed by a unit qualifier and the quantityPackage 63187-0220-00. 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 HBr is indicated for the treatment of depression. The efficacy of citalopram HBr in the treatment of depression was established in 4-6 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/or appetit…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078216
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 Hydrobromide | Citalopram hydrobromide 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-1906 |
| Citalopram | Citalopram hydrobromide 40 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0113 |
| Citalopram | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4476 |
| Citalopram Hydrobromide | Citalopram hydrobromide 40 mg/1 | TabletOral | A-S Medication Solutions | 50090-3208 |
| Citalopram Hydrobromide | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-043 |
| Citalopram Hydrobromide | Citalopram hydrobromide 20 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-2198 |
| Citalopram Hydrobromide | Citalopram hydrobromide 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5132 |
| Citalopram | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0377 |
| Citalopram Hydrobromide | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-0802 |
| Citalopram Hydrobromide | Citalopram hydrobromide 40 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0480 |
| Citalopram | Citalopram hydrobromide 40 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-071 |
| Citalopram Hydrobromide | Citalopram hydrobromide 40 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3384 |
| Citalopram | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6084 |
| Citalopram | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-664 |
| Citalopram | Citalopram hydrobromide 40 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-667 |
| Citalopram Hydrobromide | Citalopram hydrobromide 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-6846 |
| Citalopram | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6085 |
| Citalopram | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2567 |
| Citalopram | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-481 |
| Citalopram | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0557 |
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